AI Device Tracker / Radiology
FDA-authorised AI devices in radiology
1230 AI-enabled devices with radiology as the lead FDA review panel, newest first. First in this list: 1998; most recent: 2026-06-29.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-06-29 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | K253628 · 510(k) |
| 2026-06-29 | ADAS 3D | Adas3D Medical S.L. | K253969 · 510(k) |
| 2026-06-29 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | K260667 · 510(k) |
| 2026-06-26 | MammoScreen® (5) | Therapixel | K260714 · 510(k) |
| 2026-06-25 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | K253786 · 510(k) |
| 2026-06-24 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | K253560 · 510(k) |
| 2026-06-22 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | K260316 · 510(k) |
| 2026-06-18 | RadOncAI | Informai | K253050 · 510(k) |
| 2026-06-18 | ARTHUR | ROPCA ApS | K260190 · 510(k) |
| 2026-06-18 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | K260729 · 510(k) |
| 2026-06-18 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | K261713 · 510(k) |
| 2026-06-16 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | K260844 · 510(k) |
| 2026-06-15 | MediAI-OA | Crescom Co., Ltd. | K253172 · 510(k) |
| 2026-06-15 | LungMaps | Siemens Healthineers AG | K253690 · 510(k) |
| 2026-06-15 | Saige-Dx | DeepHealth, Inc. | K253825 · 510(k) |
| 2026-06-15 | WatchMate Software | Anumana, Inc. | K260300 · 510(k) |
| 2026-06-12 | Brainomix 360 Hyperdensity | Brainomix Limited | K260406 · 510(k) |
| 2026-06-11 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | K260322 · 510(k) |
| 2026-06-10 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | K253192 · 510(k) |
| 2026-06-04 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | K260497 · 510(k) |
| 2026-06-04 | Sonio Suspect | Sonio | K261519 · 510(k) |
| 2026-06-03 | HeartFocus | Deski | K260780 · 510(k) |
| 2026-05-29 | HistoSonics® Planning Tool | HistoSonics, Inc. | K252947 · 510(k) |
| 2026-05-29 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | K260077 · 510(k) |
| 2026-05-28 | ANDI 2.2 | Imeka Solutions, Inc. | K261405 · 510(k) |
| 2026-05-27 | Synapse Lung Nodule AI | Fujifilm Corporation | K254075 · 510(k) |
| 2026-05-27 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | K260123 · 510(k) |
| 2026-05-27 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | K260680 · 510(k) |
| 2026-05-22 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | K260113 · 510(k) |
| 2026-05-22 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | K260324 · 510(k) |
| 2026-05-21 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd | K253720 · 510(k) |
| 2026-05-21 | BAC | DeepHealth, Inc. | K254131 · 510(k) |
| 2026-05-21 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | K260234 · 510(k) |
| 2026-05-20 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | K253596 · 510(k) |
| 2026-05-15 | Neurophet SCALE PET | Neurophet., Inc. | K252563 · 510(k) |
| 2026-05-15 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd | K253716 · 510(k) |
| 2026-05-15 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | K254120 · 510(k) |
| 2026-05-15 | Neurophet AQUA | Neurophet., Inc. | K261273 · 510(k) |
| 2026-05-15 | UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | K261289 · 510(k) |
| 2026-05-14 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | K254013 · 510(k) |
| 2026-05-14 | BriefCase-Triage | Aidoc Medical , Ltd. | K261317 · 510(k) |
| 2026-05-13 | Morph | BeauBrain Healthcare, Inc. | K260032 · 510(k) |
| 2026-05-12 | Rayvolve | AZmed | K260378 · 510(k) |
| 2026-05-11 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | K252953 · 510(k) |
| 2026-05-05 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | K252558 · 510(k) |
| 2026-05-04 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | K252954 · 510(k) |
| 2026-04-30 | Intelligent NR | Canon, Inc. | K252503 · 510(k) |
| 2026-04-30 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | K254189 · 510(k) |
| 2026-04-29 | DeepHealth ProstateAI | Quantib B.V. | K253682 · 510(k) |
| 2026-04-29 | syngo Application Software | Siemens Medical Solutions USA, Inc. | K254184 · 510(k) |
| 2026-04-24 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL | K253459 · 510(k) |
| 2026-04-23 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | K260320 · 510(k) |
| 2026-04-23 | DS Core CBCT Anatomy | Dentsply Sirona | K260785 · 510(k) |
| 2026-04-22 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | K253077 · 510(k) |
| 2026-04-22 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | K253163 · 510(k) |
| 2026-04-20 | Folliscan | Mim Fertility | K252332 · 510(k) |
| 2026-04-17 | EdgeFlow UW20 | Edgecare, Inc. | K252237 · 510(k) |
| 2026-04-14 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | K253502 · 510(k) |
| 2026-04-10 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | K252190 · 510(k) |
| 2026-04-10 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | K252548 · 510(k) |
| 2026-04-10 | Relu Cloud | Relu BV | K252708 · 510(k) |
| 2026-04-10 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | K253689 · 510(k) |
| 2026-04-10 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | K253930 · 510(k) |
| 2026-04-06 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | K253288 · 510(k) |
| 2026-04-03 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | K260524 · 510(k) |
| 2026-04-01 | CoLumbo C-Spine | Smart Soft Healthcare AD | K254015 · 510(k) |
| 2026-03-30 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | K254207 · 510(k) |
| 2026-03-27 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | K253649 · 510(k) |
| 2026-03-27 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | K252148 · 510(k) |
| 2026-03-27 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | K254161 · 510(k) |
| 2026-03-27 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | K253595 · 510(k) |
| 2026-03-27 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K253625 · 510(k) |
| 2026-03-27 | S-scan Open (100001800) | Esaote, S.p.A. | K260746 · 510(k) |
| 2026-03-27 | Contour ProtégéAI+ | Mim Software, Inc. | K253270 · 510(k) |
| 2026-03-26 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | K253796 · 510(k) |
| 2026-03-26 | SwiftMR | Airs Medical, Inc. | K253775 · 510(k) |
| 2026-03-24 | Trinias | Shimadzu Corporation | K252099 · 510(k) |
| 2026-03-24 | JLK-NCCT | JLK, Inc. | K252421 · 510(k) |
| 2026-03-24 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | K260673 · 510(k) |
| 2026-03-23 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | K252992 · 510(k) |
| 2026-03-23 | True Definition DL | Ge Healthcare Japan Corporation | K253686 · 510(k) |
| 2026-03-20 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | K253520 · 510(k) |
| 2026-03-20 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | K253574 · 510(k) |
| 2026-03-19 | AutoContour (RADAC V5) | Radformation, Inc. | K260509 · 510(k) |
| 2026-03-18 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | K252304 · 510(k) |
| 2026-03-17 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | K253614 · 510(k) |
| 2026-03-16 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | K253944 · 510(k) |
| 2026-03-16 | Sonio Detect (v3) | Sonio | K252433 · 510(k) |
| 2026-03-13 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | K252261 · 510(k) |
| 2026-03-13 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | K260078 · 510(k) |
| 2026-03-10 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | K253584 · 510(k) |
| 2026-03-09 | LiverMultiScan (v6.0) | Perspectum, Ltd. | K253413 · 510(k) |
| 2026-03-06 | Bunkerhill Contrast CAC | BunkerHill Health | K260166 · 510(k) |
| 2026-03-06 | Bunkerhill Contrast AVC | BunkerHill Health | K260167 · 510(k) |
| 2026-03-06 | VELYS Hip Navigation | Depuy Ireland UC | K253551 · 510(k) |
| 2026-03-05 | CEPHX3D | Orca Dental AI , Ltd. | K252538 · 510(k) |
| 2026-03-05 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | K260169 · 510(k) |
| 2026-03-05 | Magnifico Open (100009900) | Esaote, S.p.A. | K251901 · 510(k) |
| 2026-03-04 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | K253898 · 510(k) |
| 2026-03-03 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | K253818 · 510(k) |
| 2026-03-02 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | K253593 · 510(k) |
| 2026-02-27 | Ligence Heart | Ligence Uab | K253535 · 510(k) |
| 2026-02-26 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | K253578 · 510(k) |
| 2026-02-24 | AI Platform 2.2 (AIP002) | Exo Imaging | K260217 · 510(k) |
| 2026-02-23 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | K253648 · 510(k) |
| 2026-02-23 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | K260265 · 510(k) |
| 2026-02-20 | CARA System | Cara Medical, Ltd. | K252500 · 510(k) |
| 2026-02-19 | Monaco RTP System (6.3) | Elekta Solutions AB | K252002 · 510(k) |
| 2026-02-13 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | K253564 · 510(k) |
| 2026-02-11 | Delivery Date AI | Ultrasound AI | DEN250007 · De Novo |
| 2026-02-11 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | K252084 · 510(k) |
| 2026-02-10 | MI View&GO | Siemens Medical Solutions USA, Inc. | K254016 · 510(k) |
| 2026-02-06 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | K251474 · 510(k) |
| 2026-02-06 | SIGNA Bolt | Ge Medical Systems, LLC | K253780 · 510(k) |
| 2026-02-05 | SIGNA Sprint Select | Ge Medical Systems, LLC | K253779 · 510(k) |
| 2026-01-30 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | K251769 · 510(k) |
| 2026-01-29 | Surgical Reality Viewer | Medicalvr B.V. | K252091 · 510(k) |
| 2026-01-29 | Neurophet AQUA AD Plus | Neurophet., Inc. | K252496 · 510(k) |
| 2026-01-28 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | K251306 · 510(k) |
| 2026-01-27 | BriefCase-Triage | Aidoc Medical , Ltd. | K251195 · 510(k) |
| 2026-01-23 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | K251351 · 510(k) |
| 2026-01-22 | AV Vascular | Philips Medical Systems Nederland B.V. | K253735 · 510(k) |
| 2026-01-22 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | K253057 · 510(k) |
| 2026-01-20 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | K253173 · 510(k) |
| 2026-01-16 | qXR-Detect | Qure.Ai Technologies | K251934 · 510(k) |
| 2026-01-16 | Imagine® Enterprise Suite | Softlink International Private Limited | K252634 · 510(k) |
| 2026-01-15 | Diagnocat | DGNCT, LLC | K252934 · 510(k) |
| 2026-01-15 | BIOGRAPH One | Siemens Healthineers AG | K253023 · 510(k) |
| 2026-01-15 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | K252188 · 510(k) |
| 2026-01-13 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | K254001 · 510(k) |
| 2026-01-08 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | K253370 · 510(k) |
| 2026-01-07 | DS Core Detect | Dentsply Sirona, Inc. | K253009 · 510(k) |
| 2026-01-07 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | K252970 · 510(k) |
| 2026-01-07 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | K253366 · 510(k) |
| 2026-01-05 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K252018 · 510(k) |
| 2025-12-30 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | K253532 · 510(k) |
| 2025-12-23 | AIR Recon DL | Ge Medical Systems, LLC | K252379 · 510(k) |
| 2025-12-23 | ART-Plan+ (v3.1.0) | Therapanacea Sas | K253091 · 510(k) |
| 2025-12-22 | PeekMed web | Peek Health, S.A. | K252856 · 510(k) |
| 2025-12-22 | BioticsAI | Bioticsai, Inc. | K250959 · 510(k) |
| 2025-12-22 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | K252557 · 510(k) |
| 2025-12-19 | Alzevita | TOPIA MEDTECH LIMITED | K252670 · 510(k) |
| 2025-12-19 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | K252838 · 510(k) |
| 2025-12-19 | AI-CVD | HeartLung Corporation | K252029 · 510(k) |
| 2025-12-18 | MediAI-BA | Crescom Co., Ltd. | K250914 · 510(k) |
| 2025-12-18 | PVAD IQ Software | Ultrasight , Ltd. | K252235 · 510(k) |
| 2025-12-17 | UltraSight Guidance | Ultrasight , Ltd. | K251416 · 510(k) |
| 2025-12-17 | Neosoma Brain Mets | Neosoma, Inc. | K252922 · 510(k) |
| 2025-12-16 | IRISeg | Intuitive Surgical, Inc. | K251763 · 510(k) |
| 2025-12-12 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | K253489 · 510(k) |
| 2025-12-11 | CogNet AI-MT+ | Medcognetics, Inc. | K252482 · 510(k) |
| 2025-12-08 | Fetal EchoScan (v1.2) | Brightheart | K252294 · 510(k) |
| 2025-12-05 | ARTAssistant | Manteia Technologies Co., Ltd. | K250780 · 510(k) |
| 2025-12-05 | Overjet CBCT Assist | Overjet, Inc. | K251514 · 510(k) |
| 2025-12-03 | AVIEW Lung Nodule CAD | Coreline Soft Co.,Ltd | K251203 · 510(k) |
| 2025-12-02 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | K252103 · 510(k) |
| 2025-12-01 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | K251370 · 510(k) |
| 2025-11-28 | CT VScore+ | Canon Medical Informatics, Inc. | K252217 · 510(k) |
| 2025-11-26 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. | K253269 · 510(k) |
| 2025-11-25 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | K250694 · 510(k) |
| 2025-11-25 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.P.A. | K253310 · 510(k) |
| 2025-11-24 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | Ge Medical Systems Ultrasound and Primary Care Diagnostics | K252328 · 510(k) |
| 2025-11-24 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | K252366 · 510(k) |
| 2025-11-21 | Senographe Pristina 3D | GE Healthcare | P130020/S005 · PMA |
| 2025-11-20 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | K251822 · 510(k) |
| 2025-11-17 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | K252086 · 510(k) |
| 2025-11-14 | Second Opinion® Panoramic | Pearl, Inc. | K250525 · 510(k) |
| 2025-11-14 | AutoDensity | Eos Imaging | K251078 · 510(k) |
| 2025-11-12 | PeekMed web | Peek Health, S.A. | K252452 · 510(k) |
| 2025-11-07 | SugarBug (1.x) | Bench7, Inc. | K250264 · 510(k) |
| 2025-11-07 | Fibresolve (with PCCP) | Imvaria, Inc. | K252041 · 510(k) |
| 2025-11-06 | BriefCase-Triage | Aidoc Medical , Ltd. | K253265 · 510(k) |
| 2025-11-03 | 3mensio Workstation | Pie Medical Imaging BV | K250330 · 510(k) |
| 2025-11-03 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | K251532 · 510(k) |
| 2025-10-31 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | K252074 · 510(k) |
| 2025-10-30 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | K250337 · 510(k) |
| 2025-10-29 | LOGIQ E10 | Ge Medical Systems Ultrasound and Primary Care Diagnostics | K251985 · 510(k) |
| 2025-10-29 | LOGIQ E10s | Ge Medical Systems Ultrasound and Primary Care Diagnostics | K251963 · 510(k) |
| 2025-10-27 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | K251027 · 510(k) |
| 2025-10-24 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | K251059 · 510(k) |
| 2025-10-23 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | K250288 · 510(k) |
| 2025-10-22 | ANDI 2.0 | Imeka Solutions, Inc. | K252298 · 510(k) |
| 2025-10-20 | brAIn Shoulder Positioning | Avatar Medical | K252665 · 510(k) |
| 2025-10-17 | X9 Ultrasound System | X9, Inc. | K251673 · 510(k) |
| 2025-10-17 | X1-FFR | Spectrawave, Inc. | K251355 · 510(k) |
| 2025-10-10 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | K251602 · 510(k) |
| 2025-10-09 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | K251651 · 510(k) |
| 2025-10-07 | AIAS Cephalon | Metamorphosis GmbH | K252214 · 510(k) |
| 2025-10-06 | BlineSlide | Deep Breathe, Inc. | K252007 · 510(k) |
| 2025-10-03 | Bunkerhill MAC | Bunkerhill Health | K250662 · 510(k) |
| 2025-10-02 | LungQ 4 | Thirona BV | K250766 · 510(k) |
| 2025-09-29 | SMART PCFD | Disior Ltd | K250023 · 510(k) |
| 2025-09-26 | Ligence Heart | Ligence, UAB | K252105 · 510(k) |
| 2025-09-25 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | K252371 · 510(k) |
| 2025-09-25 | Brain WMH | Quantib BV | K251527 · 510(k) |
| 2025-09-23 | SwiftSight-Brain | AIRS Medical Inc. | K251483 · 510(k) |
| 2025-09-23 | Rapid Aortic Measurements | iSchemaView, Inc. | K251987 · 510(k) |
| 2025-09-19 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | K251167 · 510(k) |
| 2025-09-19 | Videa Dental AI | VideaHealth Inc. | K251002 · 510(k) |
| 2025-09-18 | Axial3D Insight | Axial Medical Printing Limited | K250369 · 510(k) |
| 2025-09-17 | ECHELON Synergy | Fujifilm Corporation | K251386 · 510(k) |
| 2025-09-15 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | K250237 · 510(k) |
| 2025-09-12 | FETOLY | Diagnoly | K251368 · 510(k) |
| 2025-09-11 | SIGNA Sprint | GE Medical Systems, LLC | K251399 · 510(k) |
| 2025-09-10 | AngioWaveNet | Angiowave Imaging, Inc. | K244002 · 510(k) |
| 2025-09-09 | Segmentron Viewer | DGNCT, LLC | K251072 · 510(k) |
| 2025-09-09 | MuscleView 2.0 | Springbok, Inc. (dba Springbok Analytics) | K251682 · 510(k) |
| 2025-09-08 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | K251931 · 510(k) |
| 2025-09-08 | qER-CTA (v1.0) | Qure.ai Technologies | K251610 · 510(k) |
| 2025-09-04 | Rapid Obstructive Hydrocephalus, Rapid OH | iSchemaView Inc. | K251533 · 510(k) |
| 2025-09-04 | Dose+ (1.0) | Mvision AI Oy | K250064 · 510(k) |
| 2025-09-04 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. Ltd. | K251656 · 510(k) |
| 2025-09-03 | Tempus Pixel | Arterys, Inc. | K252539 · 510(k) |
| 2025-09-02 | OsteoSight Hip (v1) | Naitive Technologies Ltd | K251408 · 510(k) |
| 2025-09-02 | VELMENI for DENTISTS (V4D) | Velmeni Inc. | K250753 · 510(k) |
| 2025-08-29 | Sonosite LX and Sonosite PX Ultrasound Systems | Fujifilm Sonosite Inc | K251106 · 510(k) |
| 2025-08-29 | SurgiTwin | Twinsight | K250290 · 510(k) |
| 2025-08-29 | PRAEVAorta®2 | Nurea | K243859 · 510(k) |
| 2025-08-28 | Definium Tempo Select | GE Hualun Medical Systems Co., Ltd | K250788 · 510(k) |
| 2025-08-26 | Brainomix 360 Triage Stroke | Brainomix Limited | K251983 · 510(k) |
| 2025-08-22 | GBrain MRI | Galileo CDS, Inc | K252362 · 510(k) |
| 2025-08-22 | MammoScreen BD | Therapixel | K243685 · 510(k) |
| 2025-08-21 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | K251029 · 510(k) |
| 2025-08-20 | Methinks CTA Stroke | Methinks Software S.L. | K251590 · 510(k) |
| 2025-08-20 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | K251837 · 510(k) |
| 2025-08-20 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | K251481 · 510(k) |
| 2025-08-15 | VEA Align; spineEOS | EOS imaging | K251747 · 510(k) |
| 2025-08-12 | DS Core Diagnosis | Dentsply Sirona Inc. | K250755 · 510(k) |
| 2025-08-11 | Saige-Dx | DeepHealth, Inc. | K251873 · 510(k) |
| 2025-08-07 | UNiD Spine Analyzer | Medicrea International S.A.S. (Medtronic) | K251629 · 510(k) |
| 2025-08-05 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | K250246 · 510(k) |
| 2025-08-01 | Revolution Vibe | GE Medical Systems, LLC | K250941 · 510(k) |
| 2025-07-31 | Genius AI Detection 2.0 | Hologic, Inc. | K243341 · 510(k) |
| 2025-07-31 | YSIO X.pree | Siemens Medical Solutions | K250738 · 510(k) |
| 2025-07-30 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | K243919 · 510(k) |
| 2025-07-25 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary care Diagnostics, | K251322 · 510(k) |
| 2025-07-24 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K251455 · 510(k) |
| 2025-07-23 | Neuro Insight V1.0 | Olea Medical S.A.S. | K243681 · 510(k) |
| 2025-07-22 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K250901 · 510(k) |
| 2025-07-22 | GyriCalc (Version 1.0.0) | NeuroSpectrum Insights Corp. | K250686 · 510(k) |
| 2025-07-18 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K250999 · 510(k) |
| 2025-07-17 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | K243547 · 510(k) |
| 2025-07-17 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | K251839 · 510(k) |
| 2025-07-16 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | K243397 · 510(k) |
| 2025-07-16 | Rapid CTA 360 | iSchemaView | K251151 · 510(k) |
| 2025-07-16 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | K251342 · 510(k) |
| 2025-07-14 | PeekMed web | Peek Health, S.A. | K251096 · 510(k) |
| 2025-07-14 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | K250660 · 510(k) |
| 2025-07-10 | Vivid Pioneer | GE Medical Systems Ultrasound and Primary Care Diagnostics | K251169 · 510(k) |
| 2025-07-08 | TumorSight Viz | SimBioSys, Inc. | K251766 · 510(k) |
| 2025-07-07 | TAVIPILOT | Caranx Medical | K243884 · 510(k) |
| 2025-07-03 | MammoScreen® (4) | Therapixel | K243679 · 510(k) |
| 2025-07-03 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | K251528 · 510(k) |
| 2025-07-01 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging Inc. | K250221 · 510(k) |
| 2025-07-01 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | K243779 · 510(k) |
| 2025-06-30 | PIUR tUS inside | PIUR Imaging GmbH | K250484 · 510(k) |
| 2025-06-30 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | K243647 · 510(k) |
| 2025-06-30 | EchoConfidence (USA) | Mycardium AI Limited | K250670 · 510(k) |
| 2025-06-18 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound LLC | K250886 · 510(k) |
| 2025-06-18 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote S.p.A. | K243253 · 510(k) |
| 2025-06-18 | CardIQ Suite | GE Medical Systems SCS | K243672 · 510(k) |
| 2025-06-17 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | K250440 · 510(k) |
| 2025-06-16 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | K250436 · 510(k) |
| 2025-06-16 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | Siemens Healthcare GmbH | K250443 · 510(k) |
| 2025-06-16 | Methinks NCCT Stroke | Methinks Software S.L. | K250685 · 510(k) |
| 2025-06-13 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Brainlab AG | K243633 · 510(k) |
| 2025-06-12 | Second Opinion® CS | Pearl Inc. | K243234 · 510(k) |
| 2025-06-12 | Aurora | GE Medical Systems Israel | K251153 · 510(k) |
| 2025-06-10 | Viz Subdural+, Viz SUBDURAL PLUS | Viz.ai, Inc. | K250354 · 510(k) |
| 2025-06-06 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | K251009 · 510(k) |
| 2025-06-05 | BrightHeart View Classifier | BrightHeart | K251456 · 510(k) |
| 2025-06-05 | Sonic DL | GE Medical Systems, LLC | K243667 · 510(k) |
| 2025-06-04 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. | K251397 · 510(k) |
| 2025-06-04 | TraumaCad Neo (1.1) | Brainlab Ltd. | K243810 · 510(k) |
| 2025-05-30 | AudaxCeph Cephalogram Analysis Software | Audax d.o.o. | K243005 · 510(k) |
| 2025-05-30 | Swoop® Portable MR Imaging® System (V2) | Hyperfine, Inc. | K250236 · 510(k) |
| 2025-05-30 | Opulus Lymphoma Precision | Roche Molecular Systems, Inc. | K243863 · 510(k) |
| 2025-05-30 | Allix5 | Clairity, Inc. | DEN240047 · De Novo |
| 2025-05-30 | BriefCase-Triage | Aidoc Medical, Ltd. | K251406 · 510(k) |
| 2025-05-29 | Voluson Performance 16; Voluson Performance 18 | GE Medical Systems Ultrasound and Primary care Diagnostics | K250543 · 510(k) |
| 2025-05-28 | CoLumboX | Smart Soft Healthcare AD | K250367 · 510(k) |
| 2025-05-28 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | K250427 · 510(k) |
| 2025-05-28 | Rapid MLS | iSchemaview Inc. | K243378 · 510(k) |
| 2025-05-23 | Accuro 3S | Rivanna Medical, Inc. | K243937 · 510(k) |
| 2025-05-23 | DEEPECHO | DeepEcho | K242594 · 510(k) |
| 2025-05-23 | Clever One | Ewoosoft Co., Ltd | K250005 · 510(k) |
| 2025-05-23 | Second Opinion® 3D | Pearl, Inc. | K243989 · 510(k) |
| 2025-05-21 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K243793 · 510(k) |
| 2025-05-21 | Synapse 3D Base Tools (V7.0) | FUJIFILM Corporation | K243762 · 510(k) |
| 2025-05-21 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | K243122 · 510(k) |
| 2025-05-21 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | K251276 · 510(k) |
| 2025-05-20 | SCENARIA View Phase 5.0 | FUJIFILM Corporation | K250370 · 510(k) |
| 2025-05-16 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co.,Ltd. | K243617 · 510(k) |
| 2025-05-16 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote S.p.A. | K241671 · 510(k) |
| 2025-05-16 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | K240554 · 510(k) |
| 2025-05-14 | Smile Dx® | Cube Click, Inc. | K242437 · 510(k) |
| 2025-05-14 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | K242624 · 510(k) |
| 2025-05-09 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound LLC | K251110 · 510(k) |
| 2025-05-09 | Second Opinion® BLE | Pearl Inc. | K243230 · 510(k) |
| 2025-05-08 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | K250226 · 510(k) |
| 2025-05-07 | BrightHeart View Classifier | BrightHeart | K243684 · 510(k) |
| 2025-05-05 | Second Opinion® Pediatric | Pearl, Inc. | K243893 · 510(k) |
| 2025-05-02 | Fetal EchoScan (v1.1) | BrightHeart | K251071 · 510(k) |
| 2025-05-01 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | K250087 · 510(k) |
| 2025-04-30 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation | K250328 · 510(k) |
| 2025-04-28 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co.,Ltd. | K243376 · 510(k) |
| 2025-04-24 | Lung AI (LAI001) | Exo Inc | K243239 · 510(k) |
| 2025-04-23 | Annalise Enterprise | Annalise-AI | K250831 · 510(k) |
| 2025-04-21 | VersaViewer | GE Medical Systems SCS | K243651 · 510(k) |
| 2025-04-16 | LARALAB | LARALAB GmbH | K242500 · 510(k) |
| 2025-04-16 | Clarius Prostate AI | Clarius Mobile Health Corp. | K243853 · 510(k) |
| 2025-04-15 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | K250650 · 510(k) |
| 2025-04-11 | GBrain MRI | Galileo CDS, Inc | K250416 · 510(k) |
| 2025-04-11 | Oncospace | Oncospace, Inc. | K242748 · 510(k) |
| 2025-04-11 | Second Opinion Periapical Radiolucency Contours | Pearl Inc. | K242600 · 510(k) |
| 2025-04-10 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | K243145 · 510(k) |
| 2025-04-10 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K250177 · 510(k) |
| 2025-04-10 | cmAngio® (V1.6) | CureMetrix, Inc. | K250754 · 510(k) |
| 2025-04-08 | BunkerHill BMD | BunkerHill Health | K242295 · 510(k) |
| 2025-04-04 | HeartFocus (V.1.1.1) | Deski | K242807 · 510(k) |
| 2025-04-04 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | K240398 · 510(k) |
| 2025-04-04 | QFR (3.0) | QFR Solutions bv | K243769 · 510(k) |
| 2025-04-04 | DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies Inc. | K241982 · 510(k) |
| 2025-04-03 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | K242551 · 510(k) |
| 2025-04-02 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | K241984 · 510(k) |
| 2025-04-01 | MR Contour DL | GE HealthCare | K242925 · 510(k) |
| 2025-03-31 | TribusConnect | TribusMed Beheer BV | K242166 · 510(k) |
| 2025-03-27 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | K242745 · 510(k) |
| 2025-03-27 | Salix Central | Artrya Limited | K243038 · 510(k) |
| 2025-03-27 | V5med Lung AI | V5med Inc. | K242919 · 510(k) |
| 2025-03-26 | Rayvolve LN | AZmed | K243831 · 510(k) |
| 2025-03-21 | Rayvolve PTX-PE | AZmed | K243808 · 510(k) |
| 2025-03-20 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | K241961 · 510(k) |
| 2025-03-20 | brAIn Shoulder Positioning | Avatar Medical | K243292 · 510(k) |
| 2025-03-19 | AVIEW | Coreline Soft Co., Ltd. | K243689 · 510(k) |
| 2025-03-19 | PeekMed web | Peek Health, S.A. | K250042 · 510(k) |
| 2025-03-18 | QP-Prostate® CAD | Quibim S.L. | K242683 · 510(k) |
| 2025-03-17 | LVivo Software Application | DiA Imaging Analysis Ltd. | K243862 · 510(k) |
| 2025-03-17 | SIGNA Prime Elite | GE Medical Systems, LLC | K250379 · 510(k) |
| 2025-03-11 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp | K241725 · 510(k) |
| 2025-03-07 | Cleerly LABS (v2.0) | Cleerly, Inc. | K242338 · 510(k) |
| 2025-03-06 | LVivo Seamless | DiA Imaging Analysis Ltd. | K243331 · 510(k) |
| 2025-03-05 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | K241770 · 510(k) |
| 2025-03-04 | Ceevra Reveal 3+ | Ceevra, Inc. | K243933 · 510(k) |
| 2025-03-03 | LVivo Software Application | DiA Imaging Analysis Ltd. | K243235 · 510(k) |
| 2025-03-03 | JLK-SDH | JLK, Inc. | K243611 · 510(k) |
| 2025-02-28 | Myomics | Phantomics Inc. | K241922 · 510(k) |
| 2025-02-27 | ChestView US | Gleamer SAS | K241620 · 510(k) |
| 2025-02-26 | aiCockpit AI Viewer | Fovia, Inc. | K241546 · 510(k) |
| 2025-02-26 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics Ltd. | K241222 · 510(k) |
| 2025-02-25 | 3DXR | GE Medical Systems SCS | K243446 · 510(k) |
| 2025-02-25 | ART-Plan+ (v.3.0.0) | Therapanacea SAS | K242822 · 510(k) |
| 2025-02-24 | OncoStudio (OS-01) | OncoSoft. Co., Ltd. | K242994 · 510(k) |
| 2025-02-21 | QuickRad | Aikenist Technologies Pvt Ltd | K242838 · 510(k) |
| 2025-02-21 | ScanDiags Ortho L-Spine MR-Q | ScanDiags AG | K242607 · 510(k) |
| 2025-02-21 | Sonio Suspect | Sonio | K243614 · 510(k) |
| 2025-02-20 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.AI, Co., Ltd. | K242821 · 510(k) |
| 2025-02-20 | CaRi-Plaque | Caristo Diagnostics Ltd. | K242240 · 510(k) |
| 2025-02-14 | BriefCase-Triage | Aidoc Medical, Ltd. | K250248 · 510(k) |
| 2025-02-14 | Brainomix 360 e-ASPECTS | Brainomix Limited | K243294 · 510(k) |
| 2025-02-14 | AVIEW CAC | Coreline Soft Co., Ltd. | K243696 · 510(k) |
| 2025-02-12 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K243702 · 510(k) |
| 2025-02-12 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | K243523 · 510(k) |
| 2025-02-12 | SubtleHD (1.x) | Subtle Medical, Inc. | K243250 · 510(k) |
| 2025-02-11 | Vivid T9/Vivid T8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | K243628 · 510(k) |
| 2025-02-11 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | K243620 · 510(k) |
| 2025-02-10 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound LLC | K241659 · 510(k) |
| 2025-02-06 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K243794 · 510(k) |
| 2025-02-05 | BoneMetrics (US) | Gleamer SAS | K241593 · 510(k) |
| 2025-02-03 | Contour ProtégéAI+ | MIM Software Inc. | K250035 · 510(k) |
| 2025-01-27 | Bunkerhill AVC | BunkerHill Health | K243229 · 510(k) |
| 2025-01-23 | TeraRecon Aorta.CT (1.1.0) | TeraRecon, Inc. | K243158 · 510(k) |
| 2025-01-22 | Rapid Neuro3D | iSchemaView, Inc. | K243350 · 510(k) |
| 2025-01-17 | Prenuvo Body Composition | Prenuvo | K242825 · 510(k) |
| 2025-01-17 | TechCare Trauma | Milvue | K242171 · 510(k) |
| 2025-01-17 | Digital Color Doppler Ultrasound System (P60 Series) | Sonoscape Medical Corp. | K241949 · 510(k) |
| 2025-01-16 | Second Opinion CC | Pearl Inc. | K242522 · 510(k) |
| 2025-01-15 | Cardiac Guidance | Caption Health, Inc. | K243065 · 510(k) |
| 2025-01-14 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | K241166 · 510(k) |
| 2025-01-13 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | K241200 · 510(k) |
| 2025-01-10 | ScreenDx | Imvaria, Inc | K241891 · 510(k) |
| 2025-01-07 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K243335 · 510(k) |
| 2025-01-07 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | K241079 · 510(k) |
| 2025-01-06 | Soteria E-View | Omega Medical Imaging, LLC | K242488 · 510(k) |
| 2025-01-06 | Brainomix 360 e-CTA | Brainomix Limited | K242123 · 510(k) |
| 2025-01-03 | Clarify DL | GE Medical Systems Israel, Functional Imaging | K241350 · 510(k) |
| 2025-01-03 | JLK-ICH | JLK, Inc. | K243363 · 510(k) |
| 2025-01-02 | Ortho AI | Ortho AI LLC | K241696 · 510(k) |
| 2025-01-02 | Ezra Flash | Ezra AI, Inc. | K242334 · 510(k) |
| 2024-12-23 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | K242403 · 510(k) |
| 2024-12-20 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary care Diagnostics | K242168 · 510(k) |
| 2024-12-20 | Lightning Viewer | Nexsys Electronics Inc. dba Medweb | K242362 · 510(k) |
| 2024-12-19 | Saige-Density (2.5.0) | DeepHealth, Inc | K243705 · 510(k) |
| 2024-12-19 | OrthoNext Platform System | Orthofix Srl | K242270 · 510(k) |
| 2024-12-19 | IQ-UIP | Imbio, Inc. | K242467 · 510(k) |
| 2024-12-19 | Saige-Dx (3.1.0) | DeepHealth, Inc. | K243688 · 510(k) |
| 2024-12-16 | MSKai | MSKai | K240793 · 510(k) |
| 2024-12-12 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K242020 · 510(k) |
| 2024-12-12 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co.,Ltd. | K243538 · 510(k) |
| 2024-12-11 | BriefCase-Triage | Aidoc Medical, Ltd. | K243548 · 510(k) |
| 2024-12-10 | IRISeg | Intuitive Surgical Inc. | K242461 · 510(k) |
| 2024-12-10 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K242511 · 510(k) |
| 2024-12-09 | AutoContour (Model RADAC V4) | Radformation, Inc. | K242729 · 510(k) |
| 2024-12-06 | DrAid for Liver Segmentation | VinBrain Joint Stock Company | K241543 · 510(k) |
| 2024-12-06 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.AI, Co., Ltd. | K241923 · 510(k) |
| 2024-12-06 | CDM Insights | Oxford Brain Diagnostics Ltd | K240680 · 510(k) |
| 2024-12-06 | PeekMed web | Peek Health, S.A. | K240926 · 510(k) |
| 2024-12-03 | ClearRead CT CAC | Riverain Technologies, Inc. | K242188 · 510(k) |
| 2024-11-27 | Sonix Health | Ontact Health Co., Ltd | K240645 · 510(k) |
| 2024-11-27 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K242444 · 510(k) |
| 2024-11-25 | Transpara (2.1.0) | ScreenPoint Medical B.V. | K241831 · 510(k) |
| 2024-11-22 | BriefCase-Quantification | Aidoc Medical, Ltd. | K242203 · 510(k) |
| 2024-11-20 | Strain AI (SAI001) | Exo Inc | K242359 · 510(k) |
| 2024-11-19 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | K242523 · 510(k) |
| 2024-11-18 | Saige-Dx | DeepHealth, Inc | K241747 · 510(k) |
| 2024-11-15 | Koios DS | Koios Medical, Inc. | K242130 · 510(k) |
| 2024-11-15 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno Inc. | K241439 · 510(k) |
| 2024-11-15 | The 5000 Compact Series Ultrasound Systems | Philips Ultrasound LLC | K242800 · 510(k) |
| 2024-11-15 | 1CMR Pro | Mycardium AI Limited | K242062 · 510(k) |
| 2024-11-14 | Fetal EchoScan | BrightHeart | K242342 · 510(k) |
| 2024-11-08 | ProFound Detection (V4.0) | iCAD, Inc. | K240417 · 510(k) |
| 2024-11-07 | NeuroICH | Neurocareai Inc. | K241719 · 510(k) |
| 2024-11-07 | icobrain aria | icometrix NV | K240712 · 510(k) |
| 2024-11-05 | TeraRecon Cardiac.Chambers.MR (1.0.0) | TeraRecon,Inc. | K241312 · 510(k) |
| 2024-10-30 | RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic Inc. | K241108 · 510(k) |
| 2024-10-25 | TumorSight Viz | SimBioSys, Inc. | K243189 · 510(k) |
| 2024-10-25 | Neurophet AQUA (V3.1) | Neurophet, Inc. | K242215 · 510(k) |
| 2024-10-22 | nordicMEDiVA | NordicNeurolab AS | K243209 · 510(k) |
| 2024-10-18 | Contour+ (MVision AI Segmentation) | MVision AI Oy | K241490 · 510(k) |
| 2024-10-18 | BriefCase-Triage | Aidoc Medical, Ltd. | K242837 · 510(k) |
| 2024-10-17 | SIGNA MAGNUS | GE Medical Systems, LLC | K241242 · 510(k) |
| 2024-10-15 | cvi42 Software Application | Circle Cardiovascular Imaging Inc. | K242781 · 510(k) |
| 2024-10-11 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K241971 · 510(k) |
| 2024-10-10 | EchoMeasure | iCardio.ai | K241430 · 510(k) |
| 2024-10-09 | Limbus Contour | Limbus AI Inc. | K241837 · 510(k) |
| 2024-10-07 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K240980 · 510(k) |
| 2024-10-07 | SpineUs System | Verdure Imaging | K241029 · 510(k) |
| 2024-10-04 | Lunit INSIGHT DBT v1.1 | Lunit Inc. | K242652 · 510(k) |
| 2024-10-04 | EchoSolv AS | Echo IQ Ltd | K241245 · 510(k) |
| 2024-10-04 | LVivo Software Application | DiA Imaging Analysis Ltd. | K240553 · 510(k) |
| 2024-10-02 | Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics | K242005 · 510(k) |
| 2024-10-02 | MammoScreen BD | Therapixel | K241561 · 510(k) |
| 2024-10-01 | LungVision | BodyVision Medical Ltd. | K240943 · 510(k) |
| 2024-10-01 | MuscleView | Springbok, Inc. | K241331 · 510(k) |
| 2024-09-27 | CAC (gated) Algorithm | BunkerHill Health | K240369 · 510(k) |
| 2024-09-27 | JBS-LVO | JLK, Inc. | K241480 · 510(k) |
| 2024-09-24 | uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | K242292 · 510(k) |
| 2024-09-23 | MAMMOMAT B.brilliant with Tomosynthesis Option | SIEMENS MEDICAL SOLUTIONS USA, INC. | P140011/S008 · PMA |
| 2024-09-20 | PIUR tUS Infinity | PIUR Imaging GmbH | K240036 · 510(k) |
| 2024-09-12 | Constellation (CON-001) | Q Bio, Inc. | K241280 · 510(k) |
| 2024-09-12 | CINA-CSpine | Avicenna.AI | K240942 · 510(k) |
| 2024-09-12 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Canon Medical Systems Corporation | K241582 · 510(k) |
| 2024-09-11 | FETOLY-HEART | Diagnoly | K241380 · 510(k) |
| 2024-09-10 | LumiNE US; Lumi | Augmedit B.V. | K240094 · 510(k) |
| 2024-09-09 | ADAS 3D | Adas3D Medical S.L | K240791 · 510(k) |
| 2024-09-09 | Overjet Image Enhancement Assist | Overjet Inc | K241681 · 510(k) |
| 2024-09-09 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte. Ltd. | K240697 · 510(k) |
| 2024-09-06 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | K240411 · 510(k) |
| 2024-09-05 | TRAQinform IQ | AIQ Global, Inc. | K233998 · 510(k) |
| 2024-09-04 | Velacur | Sonic Incytes | K233977 · 510(k) |
| 2024-08-30 | Velmeni for Dentists (V4D) | Velmeni Inc. | K240003 · 510(k) |
| 2024-08-30 | Imbio PHA (4.0.0) | Imbio, Inc | K241847 · 510(k) |
| 2024-08-30 | uMI Panorama | Shanghai United Imaging Healthcare Co.,Ltd. | K241585 · 510(k) |
| 2024-08-30 | MI View&GO | Siemens Medical Solutions USA, Inc. | K242300 · 510(k) |
| 2024-08-30 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | K242275 · 510(k) |
| 2024-08-29 | Kosmos | EchoNous, Inc. | K233826 · 510(k) |
| 2024-08-27 | Overjet Charting Assist | Overjet, Inc | K241684 · 510(k) |
| 2024-08-22 | NeuroQuant | CorTechs Labs, Inc. | K241098 · 510(k) |
| 2024-08-21 | AiMIFY (1.x) | Subtle Medical, Inc. | K240290 · 510(k) |
| 2024-08-20 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K241496 · 510(k) |
| 2024-08-19 | HealthCCSng | Nano-X AI Ltd. | K241440 · 510(k) |
| 2024-08-16 | qCT LN Quant | Qure.ai Technologies | K240740 · 510(k) |
| 2024-08-15 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | K241596 · 510(k) |
| 2024-08-15 | CoLumbo | Smart Soft Healthcare | K241211 · 510(k) |
| 2024-08-13 | ECHELON Synergy MRI System | FUJIFILM Healthcare Corporation | K241429 · 510(k) |
| 2024-08-12 | OptimMRI (v2) | Rebrain, SAS | K242054 · 510(k) |
| 2024-08-08 | i2Contour | MRIMath LLC | K233822 · 510(k) |
| 2024-08-08 | Omni Legend | GE Medical Systems Israel, Functional Imaging | K241665 · 510(k) |
| 2024-08-05 | AI Platform 2.0 (AIP002) | Exo Imaging | K240953 · 510(k) |
| 2024-08-01 | AISAP Cardio V1.0 | Aisap | K234141 · 510(k) |
| 2024-08-01 | CardIQ Suite | GE Medical Systems SCS | K233731 · 510(k) |
| 2024-08-01 | MammoScreen® (3) | Therapixel | K240301 · 510(k) |
| 2024-07-22 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions, USA, Inc. | K240704 · 510(k) |
| 2024-07-17 | Rayvolve | AZmed SAS | K240845 · 510(k) |
| 2024-07-17 | MICSI-RMT | Microstructure Imaging, Inc. | K241121 · 510(k) |
| 2024-07-16 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | K240944 · 510(k) |
| 2024-07-12 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | K234009 · 510(k) |
| 2024-07-12 | RUS | Hutom Inc. | K233457 · 510(k) |
| 2024-07-12 | BriefCase-Triage | Aidoc Medical, Ltd. | K241727 · 510(k) |
| 2024-07-11 | SubtleSYNTH (1.x) | Subtle Medical, Inc. | K241329 · 510(k) |
| 2024-07-02 | SMART Bun-Yo-Matic X-Ray | Disior Ltd | K240736 · 510(k) |
| 2024-07-01 | Hyper Insight - ICH | SK Inc. | K240353 · 510(k) |
| 2024-06-25 | VEA Align; spineEOS | EOS imaging | K240582 · 510(k) |
| 2024-06-21 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K240631 · 510(k) |
| 2024-06-21 | O-arm O2 Imaging System | Medtronic Navigation, Inc | K240465 · 510(k) |
| 2024-06-21 | Medihub Prostate | JLK Inc. | K233196 · 510(k) |
| 2024-06-20 | SMART Bun-Yo-Matic CT | Disior Ltd | K240642 · 510(k) |
| 2024-06-14 | SIS System | Surgical Information Sciences, Inc. | K241083 · 510(k) |
| 2024-06-14 | Clarius OB AI | Clarius Mobile Health Corp. | K233955 · 510(k) |
| 2024-06-13 | Radiography 7300 C | Philips Medical Systems DMC GmbH | K233662 · 510(k) |
| 2024-06-13 | Relu Creator | Relu BV | K233925 · 510(k) |
| 2024-06-12 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K240516 · 510(k) |
| 2024-06-07 | Cardiac CT Function Software Application | Circle Cardiovascular Imaging | K241038 · 510(k) |
| 2024-06-07 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.AI Co., Ltd. | K234042 · 510(k) |
| 2024-05-31 | CINA-VCF | Avicenna.AI | K240612 · 510(k) |
| 2024-05-24 | uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | K234154 · 510(k) |
| 2024-05-24 | LVivo IQS | DiA Imaging Analysis Ltd. | K240769 · 510(k) |
| 2024-05-23 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | K240294 · 510(k) |
| 2024-05-23 | VinDr-Mammo | VinBigData Joint Stock Company | K233108 · 510(k) |
| 2024-05-21 | YSIO X.pree | Siemens Medical Solutions | K233543 · 510(k) |
| 2024-05-17 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | K233209 · 510(k) |
| 2024-05-15 | Heuron ICH | Heuron Co., Ltd. | K233247 · 510(k) |
| 2024-05-15 | BriefCase-Quantification | Aidoc Medical, Ltd. | K241112 · 510(k) |
| 2024-05-10 | SmartChest | Milvue | K232410 · 510(k) |
| 2024-05-07 | DeepContour (V1.0) | Wisdom Technologies., Inc. | K232928 · 510(k) |
| 2024-05-03 | ECHELON Synergy V10.0 | Fujifilm Healthcare Americas Corporation | K233687 · 510(k) |
| 2024-05-03 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | K232491 · 510(k) |
| 2024-04-30 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems Inc. | K232923 · 510(k) |
| 2024-04-26 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | K232799 · 510(k) |
| 2024-04-26 | Sonio Detect | Sonio | K240406 · 510(k) |
| 2024-04-26 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd | K233673 · 510(k) |
| 2024-04-25 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation | K232331 · 510(k) |
| 2024-04-24 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound LLC | K240850 · 510(k) |
| 2024-04-22 | ART-Plan (v.2.2.0) | Therapanacea SAS | K234068 · 510(k) |
| 2024-04-22 | Rapid | iSchema View Inc. | K233582 · 510(k) |
| 2024-04-17 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | K233186 · 510(k) |
| 2024-04-15 | VisAble.IO | Techsomed | K240773 · 510(k) |
| 2024-04-12 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K240238 · 510(k) |
| 2024-04-11 | True Enhance DL | GE Healthcare Japan Corporation | K233698 · 510(k) |
| 2024-04-10 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | K240744 · 510(k) |
| 2024-04-09 | Rho | 16 Bit Inc | DEN230023 · De Novo |
| 2024-04-08 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.AI, Co., Ltd. | K240291 · 510(k) |
| 2024-04-04 | Preview Shoulder | Genesis Software Innovations | K240172 · 510(k) |
| 2024-04-03 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. | K232899 · 510(k) |
| 2024-04-02 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | K232835 · 510(k) |
| 2024-04-01 | Us2.v2 | Eko.ai Pte. Ltd d/b/a Us2.ai | K233676 · 510(k) |
| 2024-03-29 | AVIEW CAC | Coreline Soft Co., Ltd. | K233211 · 510(k) |
| 2024-03-28 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | K233657 · 510(k) |
| 2024-03-26 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | K233650 · 510(k) |
| 2024-03-22 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | K232322 · 510(k) |
| 2024-03-22 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | K232431 · 510(k) |
| 2024-03-22 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | K240540 · 510(k) |
| 2024-03-21 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | K233753 · 510(k) |
| 2024-03-15 | CINA-ASPECTS | Avicenna.AI | K233342 · 510(k) |
| 2024-03-13 | CINA-iPE | Avicenna.AI | K233968 · 510(k) |
| 2024-03-07 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary care Diagnostics, | K233692 · 510(k) |
| 2024-03-06 | EdgeFlow UH10 | Edgecare Inc. | K231677 · 510(k) |
| 2024-03-04 | Overjet Caries Assist-Pediatric | Overjet, Inc | K233738 · 510(k) |
| 2024-03-01 | BoneMRI | MRIguidance B.V | K233030 · 510(k) |
| 2024-03-01 | iCAS-LV | HighRAD Ltd. | K231690 · 510(k) |
| 2024-02-29 | MAGNETOM Cima.X Fit | Siemens Medical Solutions USA, Inc. | K232765 · 510(k) |
| 2024-02-29 | inHEART Models | inHEART, SAS | K231683 · 510(k) |
| 2024-02-28 | CT Cardiomegaly | Innolitics, LLC | K232613 · 510(k) |
| 2024-02-23 | Overjet Charting Assist | Overjet, Inc | K233590 · 510(k) |
| 2024-02-22 | Revolution Ascend Sliding | GE Hangwei Medical Systems Co., Ltd. | K233749 · 510(k) |
| 2024-02-13 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K233788 · 510(k) |
| 2024-02-13 | QOCA® image Smart RT Contouring System | Quanta Computer Inc. | K231855 · 510(k) |
| 2024-02-08 | HealthFLD | Nano-X AI Ltd. | K233080 · 510(k) |
| 2024-02-05 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz.ai, Inc. | K232363 · 510(k) |
| 2024-01-31 | CEPHX- Cephalometric Analysis Software | Orca Dental AI LTD | K231396 · 510(k) |
| 2024-01-24 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation | K233195 · 510(k) |
| 2024-01-19 | SIGNA Champion | GE Healthcare (Tianjin) Company Limited | K233728 · 510(k) |
| 2024-01-19 | Rapid ASPECTS (v3) | iSchemaView, Inc. | K232156 · 510(k) |
| 2024-01-18 | NemoScan | Software Nemotec S.L. | K232698 · 510(k) |
| 2024-01-17 | Radify Triage | Envisionit DeepAI Ltd | K231871 · 510(k) |
| 2024-01-16 | Rapid (6.0) | iSchemaView, Inc. | K233512 · 510(k) |
| 2024-01-12 | Biograph VK10 | Siemens Medical Solutions USA, Inc. | K233677 · 510(k) |
| 2024-01-12 | Fibresolve | Imvaria, Inc | DEN220040 · De Novo |
| 2024-01-08 | DASI Dimensions (V1.0) | DASI Simulations | K231324 · 510(k) |
| 2024-01-08 | LungQ v3.0.0 | Thirona BV | K232412 · 510(k) |
| 2024-01-05 | VEA Align | EOS imaging | K231917 · 510(k) |
| 2024-01-04 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | K232808 · 510(k) |
| 2023-12-26 | TumorSight Viz | SimBioSys, Inc. | K231130 · 510(k) |
| 2023-12-22 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | K232535 · 510(k) |
| 2023-12-22 | ART-Plan | TheraPanacea | K232479 · 510(k) |
| 2023-12-22 | qXR-LN | Qure.ai Technologies | K231805 · 510(k) |
| 2023-12-21 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison CO., LTD. | K233112 · 510(k) |
| 2023-12-20 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | K233176 · 510(k) |
| 2023-12-18 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | K231587 · 510(k) |
| 2023-12-18 | iQ-solutions | Sydney Neuroimaging Analysis Centre Pty Ltd | K231929 · 510(k) |
| 2023-12-15 | Videa Dental Assist | VideaHealth, Inc. | K232384 · 510(k) |
| 2023-12-14 | StrokeViewer Perfusion | NICo-Lab B.V. | K231570 · 510(k) |
| 2023-12-13 | QP-Brain® | Quibim S.L. | K232231 · 510(k) |
| 2023-12-11 | Transpara Density 1.0.0 | Screenpoint Medical B.V. | K232096 · 510(k) |
| 2023-12-08 | DTX Studio Clinic (4.0) | Nobel Biocare AB | K231898 · 510(k) |
| 2023-12-08 | Bonelogic | Disior Ltd | K223757 · 510(k) |
| 2023-12-07 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary care Diagnostics, | K232381 · 510(k) |
| 2023-12-07 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | K232661 · 510(k) |
| 2023-12-06 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | K233334 · 510(k) |
| 2023-12-05 | Adravision Perio | Adra Corporation | K232440 · 510(k) |
| 2023-12-05 | Ceevra Reveal 3+ | Ceevra, Inc. | K233568 · 510(k) |
| 2023-12-01 | Syngo Carbon Clinicals | Siemens Healthcare GmbH | K232856 · 510(k) |
| 2023-11-30 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K233545 · 510(k) |
| 2023-11-29 | 6440 MyLabX90 | Esaote S.p.A. | K230179 · 510(k) |
| 2023-11-28 | BriefCase-Quantification | Aidoc Medical, Ltd. | K231631 · 510(k) |
| 2023-11-28 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | K232000 · 510(k) |
| 2023-11-21 | Brainomix 360 Triage Stroke | Brainomix Limited | K232496 · 510(k) |
| 2023-11-17 | AI Platform (AIP001) | Exo Inc | K232501 · 510(k) |
| 2023-11-15 | Axial3D Insight | Axial Medical Printing Limited | K232841 · 510(k) |
| 2023-11-14 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | Siemens Medical Solutions USA, Inc. | K232494 · 510(k) |
| 2023-11-13 | BriefCase-Quantification | Aidoc Medical, Ltd. | K232083 · 510(k) |
| 2023-11-13 | Clarius Bladder AI | Clarius Mobile Health Corp. | K232257 · 510(k) |
| 2023-11-09 | BraveCX | Bering Ltd | K223754 · 510(k) |
| 2023-11-09 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | K231617 · 510(k) |
| 2023-11-08 | BriefCase-Quantification | Aidoc Medical, Ltd. | K230534 · 510(k) |
| 2023-11-08 | Contour ProtégéAI | MIM Software Inc. | K231765 · 510(k) |
| 2023-11-07 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary care Diagnostics, | K231966 · 510(k) |
| 2023-11-07 | LOGIQ E10s, LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostic, | K231989 · 510(k) |
| 2023-11-06 | Lunit INSIGHT DBT | Lunit Inc. | K231470 · 510(k) |
| 2023-11-03 | aprevo® Digital Segmentation | Carlsmed, Inc. | K231955 · 510(k) |
| 2023-10-30 | BriefCase-Triage | Aidoc Medical, Ltd. | K232751 · 510(k) |
| 2023-10-30 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K231965 · 510(k) |
| 2023-10-30 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | K232145 · 510(k) |
| 2023-10-27 | MeVis Liver Suite | MeVis Medical Solutions AG | K232045 · 510(k) |
| 2023-10-27 | SwiftMR | AIRS Medical Inc. | K230854 · 510(k) |
| 2023-10-26 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | K232500 · 510(k) |
| 2023-10-25 | Rapid SDH | iSchemaView, Inc. | K232436 · 510(k) |
| 2023-10-23 | AI-Rad Companion Brain MR | Siemens Medical Solutions U.S.A. | K232305 · 510(k) |
| 2023-10-23 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | K231560 · 510(k) |
| 2023-10-23 | Ultrasound System 1300 | BK Medical Aps | K231764 · 510(k) |
| 2023-10-20 | Sonix Health | Ontact Health Co., Ltd. | K230209 · 510(k) |
| 2023-10-13 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | K231642 · 510(k) |
| 2023-10-13 | SpotLight/SpotLight Duo (with DLIR option) | Arineta Ltd. | K230370 · 510(k) |
| 2023-10-11 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | K230220 · 510(k) |
| 2023-10-06 | Denti.AI Detect | Denti.AI Technology, Inc. | K230144 · 510(k) |
| 2023-10-06 | Swoop® Portable MR Imaging System® | Hyperfine, Inc. | K232760 · 510(k) |
| 2023-10-05 | cmAngio® V1.0 | CureMetrix, Inc. | K232367 · 510(k) |
| 2023-10-05 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | K232704 · 510(k) |
| 2023-10-05 | DeepTek CXR Analyzer v1.0 | DeepTek Medical Imaging Pvt Ltd | K231001 · 510(k) |
| 2023-10-04 | Momentum Spine | Momentum Health Inc. | K232023 · 510(k) |
| 2023-10-04 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.AI Co., Ltd. | K231025 · 510(k) |
| 2023-10-04 | VUNO Med-DeepBrain | VUNO Inc. | K231398 · 510(k) |
| 2023-10-03 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | K232712 · 510(k) |
| 2023-10-03 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K231772 · 510(k) |
| 2023-10-03 | Lung-CAD | Imagen Technologies, Inc | K230085 · 510(k) |
| 2023-09-29 | HipCheck | Stryker Corp. | K230045 · 510(k) |
| 2023-09-28 | Brainomix 360 Triage LVO | Brainomix Limited | K231837 · 510(k) |
| 2023-09-26 | OFIX MIS App | Orthofix US LLC | K230252 · 510(k) |
| 2023-09-25 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.AI Co., Ltd. | K231928 · 510(k) |
| 2023-09-22 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd | K231767 · 510(k) |
| 2023-09-22 | qXR-CTR | Qure.ai Technologies | K231149 · 510(k) |
| 2023-09-22 | Jazz | AI Medical AG | K223659 · 510(k) |
| 2023-09-22 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd. | K231384 · 510(k) |
| 2023-09-21 | Overjet Periapical Radiolucency Assist | Overjet, Inc | K231678 · 510(k) |
| 2023-09-19 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | K231281 · 510(k) |
| 2023-09-14 | NEUROShield | In-Med Prognostics L3C | K220034 · 510(k) |
| 2023-09-13 | Lung-CAD | Imagen Technologies, Inc | K223811 · 510(k) |
| 2023-09-12 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | K231748 · 510(k) |
| 2023-09-12 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | K232526 · 510(k) |
| 2023-09-08 | DeepXray | Alpha Intelligence Manifolds, Inc. | K223621 · 510(k) |
| 2023-09-06 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | K232482 · 510(k) |
| 2023-08-30 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K230355 · 510(k) |
| 2023-08-28 | VisAble.IO | TechsoMed | K223639 · 510(k) |
| 2023-08-25 | AIRAscore | AIRAmed GmbH | K223180 · 510(k) |
| 2023-08-22 | qXR-PTX-PE | Qure.ai Technologies | K230899 · 510(k) |
| 2023-08-15 | Annalise Enterprise CTB Triage-OH | Annalise-AI Pty Ltd | K231094 · 510(k) |
| 2023-08-03 | VisiRad XR | Imidex Inc. | K223133 · 510(k) |
| 2023-07-27 | Brainomix 360 Triage ICH | Brainomix Limited | K231195 · 510(k) |
| 2023-07-27 | Rapid Aneurysm Triage and Notification | iSchemaView Inc. | K230074 · 510(k) |
| 2023-07-26 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | K231572 · 510(k) |
| 2023-07-25 | ANDI | Imeka Solutions, Inc. | K230913 · 510(k) |
| 2023-07-25 | Sonio Detect | Sonio | K230365 · 510(k) |
| 2023-07-24 | UltraSight AI Guidance | UltraSight Inc. | K223347 · 510(k) |
| 2023-07-21 | OptimMRI | RebrAIn, SAS | K230150 · 510(k) |
| 2023-07-20 | uOmnispace | Shanghai United Imaging Healthcare Co., Ltd | K230039 · 510(k) |
| 2023-07-19 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | K231157 · 510(k) |
| 2023-07-14 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Brainlab AG | K223106 · 510(k) |
| 2023-07-14 | Ez3D-i /E3 | Ewoosoft Co., Ltd | K231757 · 510(k) |
| 2023-07-13 | Biograph Vision.X and Biograph Vision.X Edge | Siemens Medical Solutions USA, Inc. | K231833 · 510(k) |
| 2023-07-13 | Spine Auto Views | GE Medical Systems SCS | K223424 · 510(k) |
| 2023-07-13 | ECHELON Synergy MRI system | FUJIFILM Healthcare Corporation | K223426 · 510(k) |
| 2023-07-10 | MOZI TPS | Manteia Technologies Co., Ltd. | K223724 · 510(k) |
| 2023-07-07 | Spine CAMP (1.1) | Medical Metrics, Inc. | K231668 · 510(k) |
| 2023-07-03 | Axial3D Insight | Axial Medical Printing Limited | K222745 · 510(k) |
| 2023-06-22 | Bladder AI (AIBV01) | Exo Inc | K230497 · 510(k) |
| 2023-06-20 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty Ltd | K231459 · 510(k) |
| 2023-06-20 | Voluson SWIFT; Voluson SWIFT+ | GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC | K230346 · 510(k) |
| 2023-06-16 | DeepCatch | MEDICALIP Co., Ltd | K223556 · 510(k) |
| 2023-06-16 | IB Lab LAMA | IB Lab GmbH | K223646 · 510(k) |
| 2023-06-13 | CAC Software | Imbio, Inc. | K230112 · 510(k) |
| 2023-06-06 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | FEops nv | K223855 · 510(k) |
| 2023-05-30 | Sonic DL | GE Medical Systems,LLC (GE Healthcare) | K223523 · 510(k) |
| 2023-05-25 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Medical Systems, LLC | K223491 · 510(k) |
| 2023-05-23 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | K230096 · 510(k) |
| 2023-05-19 | Autoplaque | Cedars-Sinai Medical Center: AIM | K212758 · 510(k) |
| 2023-05-17 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | K222728 · 510(k) |
| 2023-05-12 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound LLC | K231190 · 510(k) |
| 2023-05-11 | SubtleMR (2.3.x) | Subtle Medical Inc. | K223623 · 510(k) |
| 2023-05-10 | Neurophet AQUA | NEUROPHET, Inc. | K220437 · 510(k) |
| 2023-05-04 | Auto Segmentation | GE Medical Systems, LLC | K230082 · 510(k) |
| 2023-05-04 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | K223771 · 510(k) |
| 2023-05-02 | SIS System | Surgical Information Sciences, Inc. | K230977 · 510(k) |
| 2023-04-27 | Precision DL | GE Healthcare | K223212 · 510(k) |
| 2023-04-26 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | K230552 · 510(k) |
| 2023-04-25 | iCAC Device | Bunkerhill, Inc | K230223 · 510(k) |
| 2023-04-25 | Ceevra Reveal 3 | Ceevra, Inc. | K222676 · 510(k) |
| 2023-04-21 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | K230084 · 510(k) |
| 2023-04-21 | ViewFinder Software Version 1.1 | Elaitra Ltd | K223501 · 510(k) |
| 2023-04-20 | Velacur | Sonic Incytes | K223287 · 510(k) |
| 2023-04-20 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | K230807 · 510(k) |
| 2023-04-19 | ART-Plan | Therapanacea SAS | K230023 · 510(k) |
| 2023-04-17 | Quantib Prostate | Quantib BV | K230772 · 510(k) |
| 2023-04-14 | AutoContour Model RADAC V3 | Radformation, Inc. | K230685 · 510(k) |
| 2023-04-13 | Ezra Flash | Ezra AI, Inc. | K230264 · 510(k) |
| 2023-04-13 | CerebralGo Plus | Yukun (Beijing) Technology Co., Ltd | K213986 · 510(k) |
| 2023-04-11 | Ultrasound System 2300 | BK Medical Aps | K223830 · 510(k) |
| 2023-04-07 | Limbus Contour | Limbus AI Inc. | K230575 · 510(k) |
| 2023-04-06 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | K222360 · 510(k) |
| 2023-04-06 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | K223458 · 510(k) |
| 2023-04-06 | Contour ProtégéAI | MIM Software Inc. | K223774 · 510(k) |
| 2023-04-03 | Annalise Enterprise CTB Triage Trauma | Annalise-AI Pty Ltd | K223240 · 510(k) |
| 2023-03-31 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | K220068 · 510(k) |
| 2023-03-31 | Formus Hip | Formus Labs, Ltd | K213272 · 510(k) |
| 2023-03-29 | RayStation 12A | RaySearch Laboratories AB (publ) | K222312 · 510(k) |
| 2023-03-28 | DTX Studio Clinic 3.0 | Nobel Biocare AB | K221921 · 510(k) |
| 2023-03-28 | RadioLens v1.0 | Synapsica | K222174 · 510(k) |
| 2023-03-28 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | K222179 · 510(k) |
| 2023-03-28 | Annalise Enterprise CXR Triage Trauma | Annalise-AI Pty Ltd | K222268 · 510(k) |
| 2023-03-28 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA Inc. | K223343 · 510(k) |
| 2023-03-27 | Overjet Caries Assist | Overjet, Inc. | K222746 · 510(k) |
| 2023-03-22 | MPXA-2000 | Medipixel, Inc. | K222036 · 510(k) |
| 2023-03-21 | FlightPlan for Embolization | GE Medical Systems SCS | K223490 · 510(k) |
| 2023-03-17 | Viz AAA | Viz. ai, Inc. | K223443 · 510(k) |
| 2023-03-10 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | K223325 · 510(k) |
| 2023-03-09 | Spectral Bone Marrow | GE Medical Systems, LLC | K223514 · 510(k) |
| 2023-03-09 | AccuContour | Manteia Technologies Co., Ltd. | K221706 · 510(k) |
| 2023-03-07 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | K223726 · 510(k) |
| 2023-03-03 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | K222819 · 510(k) |
| 2023-03-02 | BoneView | Gleamer | K222176 · 510(k) |
| 2023-03-02 | Rapid NCCT Stroke | iSchemaView, Inc. | K222884 · 510(k) |
| 2023-03-01 | Xeleris V Processing and Review System | GE Healthcare | K221680 · 510(k) |
| 2023-02-24 | Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc | DEN220063 · De Novo |
| 2023-02-24 | AVIEW Lung Nodule CAD | Coreline Soft Co.,Ltd. | K221592 · 510(k) |
| 2023-02-23 | Brainomix 360 e-ASPECTS | Brainomix Limited | K221564 · 510(k) |
| 2023-02-22 | BoneMRI v1.6 | MRIguidance B.V. | K230197 · 510(k) |
| 2023-02-22 | Swoop® Portable MR Imaging System | Hyperfine, Inc. | K230208 · 510(k) |
| 2023-02-16 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | K223028 · 510(k) |
| 2023-02-16 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | K222755 · 510(k) |
| 2023-02-13 | SIGNA Victor | GE Healthcare (Tianjin) Company Limited | K223439 · 510(k) |
| 2023-02-13 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K223387 · 510(k) |
| 2023-02-06 | Videa Perio Assist | VideaHealth, Inc. | K223296 · 510(k) |
| 2023-02-02 | Oncospace | Oncospace, Inc. | K222803 · 510(k) |
| 2023-02-01 | LVivo IQS | DiA Imaging Analysis Ltd | K222970 · 510(k) |
| 2023-02-01 | Rapid RV/LV | iSchema View Inc. | K223396 · 510(k) |
| 2023-02-01 | BriefCase | Aidoc Medical, Ltd. | K230020 · 510(k) |
| 2023-01-27 | QOCA image Smart CXR Image Processing System | Quanta Computer Inc. | K221868 · 510(k) |
| 2023-01-23 | Clarius AI | Clarius Mobile Health Corp. | K222406 · 510(k) |
| 2023-01-18 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | K222593 · 510(k) |
| 2023-01-13 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | K223502 · 510(k) |
| 2023-01-12 | AIBOLIT 3D+ | Aibolit Technologies, LLC | K222458 · 510(k) |
| 2022-12-23 | AVIEW | Coreline Soft Co.,Ltd. | K214036 · 510(k) |
| 2022-12-23 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | K223442 · 510(k) |
| 2022-12-22 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd | K223311 · 510(k) |
| 2022-12-16 | Overjet Calculus Assist | Overjet Inc. | K220928 · 510(k) |
| 2022-12-16 | BrainInsight | Hyperfine, Inc. | K223268 · 510(k) |
| 2022-12-16 | Saige-Density | DeepHealth, Inc. | K222275 · 510(k) |
| 2022-12-06 | Swoop Portable MR Imaging System | Hyperfine, Inc. | K223247 · 510(k) |
| 2022-12-05 | BriefCase | Aidoc Medical, Ltd. | K222692 · 510(k) |
| 2022-11-22 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | K221624 · 510(k) |
| 2022-11-22 | CINA | AVICENNA.AI | K221716 · 510(k) |
| 2022-11-21 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | K223032 · 510(k) |
| 2022-11-18 | BriefCase | Aidoc Medical, Ltd. | K221330 · 510(k) |
| 2022-11-16 | BoneMRI v1.4 | MRlguidance B.V. | K221762 · 510(k) |
| 2022-11-14 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | K222428 · 510(k) |
| 2022-11-10 | AVIEW RT ACS | Coreline Soft Co.,Ltd | K220408 · 510(k) |
| 2022-11-08 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune AI Co., Ltd. | K221552 · 510(k) |
| 2022-10-27 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd. | K220332 · 510(k) |
| 2022-10-25 | EndoNaut | Therenva SAS | K222070 · 510(k) |
| 2022-10-21 | Viz LVO ContaCT | Viz.ai, Inc. | K223042 · 510(k) |
| 2022-10-20 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | K222361 · 510(k) |
| 2022-10-18 | Spine CAMP | Medical Metrics, Inc. | K221632 · 510(k) |
| 2022-10-14 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc | K221305 · 510(k) |
| 2022-10-07 | BriefCase | Aidoc Medical, Ltd. | K220709 · 510(k) |
| 2022-10-06 | Genius AI Detection 2.0 | Hologic, Inc. | K221449 · 510(k) |
| 2022-09-30 | QIR Suite | CASIS Cardiac Simulation & Imaging Software | K211611 · 510(k) |
| 2022-09-29 | CogNet QmTRIAGE | MedCognetics, Inc. | K220080 · 510(k) |
| 2022-09-28 | BriefCase | Aidoc Medical, Ltd. | K222329 · 510(k) |
| 2022-09-27 | NS-HGlio | Neosoma Inc. | K221738 · 510(k) |
| 2022-09-20 | Aorta-CAD | Imagen Technologies, Inc | K213353 · 510(k) |
| 2022-09-13 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutions USA, Inc. | K221733 · 510(k) |
| 2022-09-12 | Rapid ICH | iSchemaView Inc. | K221456 · 510(k) |
| 2022-09-12 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | K220986 · 510(k) |
| 2022-09-08 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.AI Co., Ltd. | K222076 · 510(k) |
| 2022-09-07 | syngo.via RT Image Suite | Siemens Medical Solutions USA Inc. | K220783 · 510(k) |
| 2022-09-06 | LiverMultiScan v5 (LMSv5) | Perspectum | K213960 · 510(k) |
| 2022-09-01 | DrAid for Radiology v1 | VinBrain Joint Stock Company | K221241 · 510(k) |
| 2022-08-29 | Viz RV/LV | Viz.ai, Inc. | K221100 · 510(k) |
| 2022-08-26 | BriefCase | Aidoc Medical, Ltd. | K222277 · 510(k) |
| 2022-08-25 | MRI Planner | Spectronic Medical AB | K211841 · 510(k) |
| 2022-08-24 | AutoContour Model RADAC V2 | Radformation, Inc. | K220598 · 510(k) |
| 2022-08-22 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K221599 · 510(k) |
| 2022-08-19 | MI View&GO | Siemens Medical Solutions USA, Inc. | K222172 · 510(k) |
| 2022-08-12 | TeraRecon Neuro | TeraRecon, Inc | K220349 · 510(k) |
| 2022-08-11 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmBh | K213713 · 510(k) |
| 2022-08-08 | ClearPoint Maestro Brain Model | ClearPoint Neuro, Inc. | K213645 · 510(k) |
| 2022-08-03 | Customize | 3D-Side SA | K221432 · 510(k) |
| 2022-08-03 | Transpara 1.7.2 | ScreenPoint Medical B.V. | K221347 · 510(k) |
| 2022-07-29 | ABMD Software | HeartLung Corporation | K213760 · 510(k) |
| 2022-07-29 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | K220961 · 510(k) |
| 2022-07-28 | Swoop Portable MR Imaging System | Hyperfine, Inc. | K221923 · 510(k) |
| 2022-07-28 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging Inc | K213998 · 510(k) |
| 2022-07-25 | Viz SDH | Viz.ai, Inc. | K220439 · 510(k) |
| 2022-07-22 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K220940 · 510(k) |
| 2022-07-22 | AI4CMR v1.0 | AI4MedImaging Medical Solutions S.A. | K220624 · 510(k) |
| 2022-07-22 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and | K220882 · 510(k) |
| 2022-07-20 | Libby Echo:Prio | Dyad Medical, Inc | K220956 · 510(k) |
| 2022-07-19 | BrainInsight | Hyperfine, Inc. | K220815 · 510(k) |
| 2022-07-18 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | K221148 · 510(k) |
| 2022-07-18 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K221147 · 510(k) |
| 2022-07-15 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K220619 · 510(k) |
| 2022-07-13 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | K221727 · 510(k) |
| 2022-07-08 | ProstatID | ScanMed, LLC | K212783 · 510(k) |
| 2022-06-29 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K220975 · 510(k) |
| 2022-06-27 | Venue | GE Medical Systems | K220851 · 510(k) |
| 2022-06-27 | Venue Fit | GE Medical Systems | K220848 · 510(k) |
| 2022-06-24 | MAGNETOM Free.Max, MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | K220575 · 510(k) |
| 2022-06-23 | CoLumbo | Smart Soft Healthcare AD | K220497 · 510(k) |
| 2022-06-21 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | K220800 · 510(k) |
| 2022-06-17 | ART-PLAN | TheraPanacea | K220813 · 510(k) |
| 2022-06-17 | ElucidVivo A.3 | Elucid Bioimaging Inc. | K221463 · 510(k) |
| 2022-06-16 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | K213504 · 510(k) |
| 2022-06-10 | Swoop Portable MR Imaging System | Hyperfine, Inc. | K221393 · 510(k) |
| 2022-06-08 | AIR Recon DL | GE Medical Systems,LLC (GE Healthcare) | K213717 · 510(k) |
| 2022-06-06 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K220358 · 510(k) |
| 2022-06-03 | BriefCase | Aidoc Medical, Ltd. | K221314 · 510(k) |
| 2022-06-02 | Rayvolve | AZmed SAS | K220164 · 510(k) |
| 2022-05-31 | Rapid LVO | iSchemaView Inc. | K221248 · 510(k) |
| 2022-05-25 | SwiftMR | AIRS Medical Inc. | K220416 · 510(k) |
| 2022-05-17 | BriefCase | Aidoc Medical, Ltd. | K221240 · 510(k) |
| 2022-05-17 | Rapid PE Triage and Notification (PETN) | iSchemaView Inc. | K220499 · 510(k) |
| 2022-05-17 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | K221219 · 510(k) |
| 2022-05-16 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | K213583 · 510(k) |
| 2022-05-13 | Quantib Prostate | Quantib BV | K221106 · 510(k) |
| 2022-05-13 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. | K220589 · 510(k) |
| 2022-05-12 | Saige-Dx | DeepHealth, Inc. | K220105 · 510(k) |
| 2022-05-11 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K220446 · 510(k) |
| 2022-05-10 | Overjet Caries Assist | Overjet, Inc. | K212519 · 510(k) |
| 2022-05-06 | Segment 3DPrint | Medviso AB | K211966 · 510(k) |
| 2022-05-03 | MVision AI Segmentation | MVision AI | K212915 · 510(k) |
| 2022-04-29 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | Siemens Medical Solutions USA Inc. | K220939 · 510(k) |
| 2022-04-29 | aPROMISE X | EXINI Diagnostics AB | K220590 · 510(k) |
| 2022-04-28 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.AI Co., Ltd. | K220264 · 510(k) |
| 2022-04-27 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | K212441 · 510(k) |
| 2022-04-26 | BriefCase | Aidoc Medical, Ltd. | K213886 · 510(k) |
| 2022-04-22 | HealthOST | NanoxAI Ltd. | K213944 · 510(k) |
| 2022-04-21 | Videa Caries Assist | VideaHealth, Inc | K213795 · 510(k) |
| 2022-04-15 | AI-Rad Companion Brain MR | Siemens Healthcare GmBh | K213706 · 510(k) |
| 2022-04-15 | RayStation 11B | RaySearch Laboratories AB (publ) | K220141 · 510(k) |
| 2022-04-08 | Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K220192 · 510(k) |
| 2022-04-08 | INT Contour | Carina Medical LLC | K212274 · 510(k) |
| 2022-04-06 | ClariPulmo | ClariPi Inc. | K203783 · 510(k) |
| 2022-04-05 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., LTD | K220043 · 510(k) |
| 2022-04-05 | MRCAT Head & Neck | Philips Oy | K214081 · 510(k) |
| 2022-04-04 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune. AI Co., Ltd. | K212624 · 510(k) |
| 2022-04-01 | MAGNETOM Avanto Fit | Siemens Medical Solutions USA, Inc. | K220151 · 510(k) |
| 2022-03-22 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | K212960 · 510(k) |
| 2022-03-21 | BriefCase | Aidoc Medical, Ltd. | K213721 · 510(k) |
| 2022-03-16 | Customize | 3D-Side SA | K213779 · 510(k) |
| 2022-03-14 | BriefCase | Aidoc Medical, Ltd. | K214043 · 510(k) |
| 2022-03-14 | Arterys MICA | Arterys Inc. | K203744 · 510(k) |
| 2022-03-11 | CardIQ Suite | GE Medical Systems SCS | K213725 · 510(k) |
| 2022-03-10 | ClearRead Xray Pneumothorax | Riverain Technologies, Inc. | K213566 · 510(k) |
| 2022-03-04 | Second Opinion | Pearl Inc. | K210365 · 510(k) |
| 2022-03-01 | BoneView | Gleamer | K212365 · 510(k) |
| 2022-02-25 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | K213693 · 510(k) |
| 2022-02-24 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-AI | K213941 · 510(k) |
| 2022-02-18 | Viz ANEURYSM, Viz ANX | Viz.ai, Inc. | K213319 · 510(k) |
| 2022-02-18 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | K213999 · 510(k) |
| 2022-02-17 | Voluson P6, Voluson P8 | GE Healthcare | K213689 · 510(k) |
| 2022-02-11 | SIGNA Artist Evo | GE Healthcare(Tianjin) Company Limited | K213603 · 510(k) |
| 2022-02-08 | Rapid | iSchema View Inc. | K213165 · 510(k) |
| 2022-02-04 | Micro C Medical Imaging System, M01 | OXOS Medical, Inc. | K212654 · 510(k) |
| 2022-02-04 | Revolution Ascend | GE Healthcare Japan Corporation | K213938 · 510(k) |
| 2022-02-03 | Contour ProtégéAI | MIM Software Inc. | K213976 · 510(k) |
| 2022-01-28 | syngo.CT Brain Hemorrhage | Siemens Medical Solutions USA, Inc. | K203260 · 510(k) |
| 2022-01-24 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Canon Medical Systems Corporation | K212333 · 510(k) |
| 2022-01-20 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | K214019 · 510(k) |
| 2022-01-20 | SIGNA Hero | GE Healthcare (GE Medical Systems, LLC) | K213668 · 510(k) |
| 2022-01-19 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | K210747 · 510(k) |
| 2022-01-19 | Follicle Clarity | Cycle Clarity | K212012 · 510(k) |
| 2022-01-16 | SIGNA Prime | GE Healthcare (Tianjin) Company Limited | K211980 · 510(k) |
| 2022-01-14 | Precise Image | Philips Medical Systems Nederland, B.V. | K210760 · 510(k) |
| 2022-01-14 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | K213307 · 510(k) |
| 2022-01-14 | Quantib ND | Quantib B.V. | K213737 · 510(k) |
| 2022-01-13 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | GE Healthcare | K213642 · 510(k) |
| 2022-01-12 | UNiD Spine Analyzer | MEDICREA International, Inc. | K212005 · 510(k) |
| 2022-01-07 | AIBOLIT 3D+ | AIbolit Technologies, LLC | K211443 · 510(k) |
| 2022-01-06 | TOMTEC-ARENA | TOMTEC Imaging Systems GmbH | K213544 · 510(k) |
| 2021-12-29 | LiverSmart | Resonance Health Analysis Services Pty Ltd | K213776 · 510(k) |
| 2021-12-22 | BoneMRI | MRIguidance B.V | K202404 · 510(k) |
| 2021-12-21 | qXR-BT | Qure.ai Technologies | K212690 · 510(k) |
| 2021-12-21 | BU-CAD | TaiHao Medical Inc. | K210670 · 510(k) |
| 2021-12-20 | EchoGo Core (2.0) | Ultromics Limited | K213275 · 510(k) |
| 2021-12-16 | VBrain | Vysioneer Inc. | K213628 · 510(k) |
| 2021-12-16 | Koios DS | Koios Medical, Inc. | K212616 · 510(k) |
| 2021-12-15 | RT-Mind-AI | MedMind Technology Co., Ltd. | K213155 · 510(k) |
| 2021-12-15 | HealthPPT | Zebra Medical Vision Ltd. | K211803 · 510(k) |
| 2021-12-09 | LVivo Seamless | DiA Imaging Analysis Ltd | K212466 · 510(k) |
| 2021-12-06 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | K213096 · 510(k) |
| 2021-12-03 | Cydar EV (Series B) and Cydar EV Maps | Cydar Ltd. | K212442 · 510(k) |
| 2021-12-01 | Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K213305 · 510(k) |
| 2021-11-26 | MammoScreen 2.0 | Therapixel | K211541 · 510(k) |
| 2021-11-19 | OnQ Neuro | CorTechs Labs, Inc | K210831 · 510(k) |
| 2021-11-17 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine, Inc. | K212456 · 510(k) |
| 2021-11-17 | Soteria.AI | Omega Medical Imaging, LLC | K212336 · 510(k) |
| 2021-11-17 | Lunit INSIGHT MMG | Lunit Inc. | K211678 · 510(k) |
| 2021-11-16 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | K212265 · 510(k) |
| 2021-11-15 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | K213436 · 510(k) |
| 2021-11-10 | Lunit INSIGHT CXR Triage | Lunit Inc. | K211733 · 510(k) |
| 2021-10-29 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | GE Medical Systems, LLC | K211161 · 510(k) |
| 2021-10-25 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | K212218 · 510(k) |
| 2021-10-22 | FlightPlan for Liver | GE Medical Systems SCS | K210807 · 510(k) |
| 2021-10-20 | Contour ProtegeAI | MIM Software Inc. | K210632 · 510(k) |
| 2021-10-14 | SwiftMR | AIRS Medical Inc. | K210999 · 510(k) |
| 2021-10-14 | StrokeSENS LVO | Circle Neurovascular Imaging, Inc | K212261 · 510(k) |
| 2021-10-12 | VBrain-OAR | Vysioneer Inc. | K212116 · 510(k) |
| 2021-09-28 | SubtlePET | Subtle Medical, Inc. | K211964 · 510(k) |
| 2021-09-24 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | Philips Medical Systems | K212704 · 510(k) |
| 2021-09-17 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | K212067 · 510(k) |
| 2021-09-17 | Intelligent NR | Canon Inc. | K212269 · 510(k) |
| 2021-09-15 | HealthCCSng | Zebra Medical Vision Ltd. | K210085 · 510(k) |
| 2021-09-10 | ClariSIGMAM | ClariPi Inc. | K203785 · 510(k) |
| 2021-09-10 | Versana Premier | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K210438 · 510(k) |
| 2021-09-10 | Aquilion Exceed LB | Canon Medical Systems Corporation | K211828 · 510(k) |
| 2021-09-09 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | K211824 · 510(k) |
| 2021-09-08 | V8 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | K211945 · 510(k) |
| 2021-09-08 | AmCAD-UT | AmCad BioMed Corporation | K203555 · 510(k) |
| 2021-09-08 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Medical Systems | K211597 · 510(k) |
| 2021-09-08 | RayStation 11.0 | RaySearch Laboratories AB (publ) | K211867 · 510(k) |
| 2021-09-02 | AI Segmentation | Varian Medical Systems, Inc. | K211881 · 510(k) |
| 2021-08-31 | Auto Lung Nodule Detection | Samsung Electronics Co.,Ltd. | K201560 · 510(k) |
| 2021-08-31 | EndoNaut | Therenva SAS | K212383 · 510(k) |
| 2021-08-27 | RBknee | Radiobotics ApS | K203696 · 510(k) |
| 2021-08-20 | Discovery MI Gen2 | GE Medical Systems, LLC. | K211846 · 510(k) |
| 2021-08-16 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical Ltd | K212230 · 510(k) |
| 2021-08-12 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | K211179 · 510(k) |
| 2021-08-11 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | K203448 · 510(k) |
| 2021-08-06 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | K211764 · 510(k) |
| 2021-08-06 | Kosmos | EchoNous, Inc. | K212100 · 510(k) |
| 2021-08-02 | breastscape v1.0 | Olea Medical | K211431 · 510(k) |
| 2021-07-30 | qER-Quant | Qure.ai Technologies | K211222 · 510(k) |
| 2021-07-30 | syngo.via RT Image Suite | Siemens Medical Solutions USA Inc. | K211379 · 510(k) |
| 2021-07-27 | aPROMISE | EXINI Diagnostics AB | K211655 · 510(k) |
| 2021-07-27 | ClariCT.AI | ClariPi Inc. | K212074 · 510(k) |
| 2021-07-27 | Volpara Imaging Software | Volpara Health Technologies Limited | K211279 · 510(k) |
| 2021-07-27 | Us2.v1 | eko.ai Pte. Ltd. d/b/a Us2.ai | K210791 · 510(k) |
| 2021-07-20 | Chest-CAD | Imagen Technologies, Inc | K210666 · 510(k) |
| 2021-07-20 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | K210719 · 510(k) |
| 2021-07-12 | PowerLook Density Assessment V4.0 | iCAD, Inc. | K211506 · 510(k) |
| 2021-07-08 | HALO | Nico.Lab B.V. | K211788 · 510(k) |
| 2021-07-01 | MAGNETOM Free.Max | Siemens Medical Solutions USA, Inc. | K210611 · 510(k) |
| 2021-06-29 | RayStation 10.1 | RaySearch Laboratories AB (publ) | K210645 · 510(k) |
| 2021-06-17 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | K203514 · 510(k) |
| 2021-06-16 | Qmenta Care Platform Family | Mint Labs, Inc., d/b/a. QMENTA | K202718 · 510(k) |
| 2021-06-10 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | K211459 · 510(k) |
| 2021-06-08 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | Abbott Medical | K210458 · 510(k) |
| 2021-06-02 | Transpara 1.7.0 | ScreenPoint Medical B.V. | K210404 · 510(k) |
| 2021-05-19 | CINA CHEST | Avicenna.AI | K210237 · 510(k) |
| 2021-05-19 | Overjet Dental Assist | Overjet, Inc. | K210187 · 510(k) |
| 2021-05-13 | SIGNA 7.0T | GE Medical Systems, LLC | K211118 · 510(k) |
| 2021-05-13 | HS40 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | K210426 · 510(k) |
| 2021-04-30 | HYPER AiR | Shanghai United Imaging Healthcare Co.,Ltd. | K210001 · 510(k) |
| 2021-04-23 | Cartesion Prime (PCD-1000A/3) V10.8 | Canon Medical Systems Corporation | K203314 · 510(k) |
| 2021-04-23 | MEDO-Thyroid | MEDO DX Pte. Ltd. | K203502 · 510(k) |
| 2021-04-21 | Preview Shoulder | Genesis Software Innovations | K210556 · 510(k) |
| 2021-04-20 | Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | K203610 · 510(k) |
| 2021-04-19 | AI Segmentation | Varian Medical Systems, Inc. | K203469 · 510(k) |
| 2021-04-16 | Saige-Q | DeepHealth, Inc. | K203517 · 510(k) |
| 2021-04-14 | BriefCase, RIB Fractures Triage (RibFx) | Aidoc Medical, Ltd. | K202992 · 510(k) |
| 2021-04-02 | DV. Target | Deepvoxel INC | K202928 · 510(k) |
| 2021-04-02 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | K202441 · 510(k) |
| 2021-03-31 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | K210071 · 510(k) |
| 2021-03-31 | syngo.CT Lung CAD | Siemens Healthcare GmbH | K203258 · 510(k) |
| 2021-03-31 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | K203443 · 510(k) |
| 2021-03-24 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems Corporation | K203225 · 510(k) |
| 2021-03-23 | Viz ICH | Viz.ai, Inc. | K210209 · 510(k) |
| 2021-03-19 | VBrain | Vysioneer Inc. | K203235 · 510(k) |
| 2021-03-12 | Oncospace | Oncospace, Inc. | K202284 · 510(k) |
| 2021-03-12 | ProFound AI Software V3.0 | iCAD Inc. | K203822 · 510(k) |
| 2021-03-09 | Imbio RV/LV Software | Imbio, LLC | K203256 · 510(k) |
| 2021-03-05 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Optellum Ltd | K202300 · 510(k) |
| 2021-03-04 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K203323 · 510(k) |
| 2021-03-02 | MaxFOV 2 | GE Medical Systems, LLC. | K203617 · 510(k) |
| 2021-02-26 | SubtleMR | Subtle Medical, Inc. | K203182 · 510(k) |
| 2021-02-25 | NinesMeasure | Nines, Inc. | K202990 · 510(k) |
| 2021-02-25 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging AI, Inc. | K203578 · 510(k) |
| 2021-02-19 | TruPlan | Circle Cardiovascular Imaging Inc. | K202212 · 510(k) |
| 2021-02-09 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | K203103 · 510(k) |
| 2021-02-05 | LVivo Software Application | DiA Imaging Analysis Ltd | K210053 · 510(k) |
| 2021-02-04 | QUIBIM Precision Prostate (qp-Prostate) | QUIBIM S.L. | K203582 · 510(k) |
| 2021-01-29 | Visage Breast Density | Visage Imaging GmbH | K201411 · 510(k) |
| 2021-01-15 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | K202767 · 510(k) |
| 2021-01-15 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | K193271 · 510(k) |
| 2021-01-14 | ART-Plan | TheraPanacea | K202700 · 510(k) |
| 2021-01-12 | Hepatica v1 (Hepatica v1.0.0) | Perspectum Ltd. | K203280 · 510(k) |
| 2021-01-12 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | K201836 · 510(k) |
| 2021-01-11 | Imagio Breast Imaging System | Seno Medical Instruments, Inc. | P200003 · PMA |
| 2021-01-07 | BrainInsight | Hyperfine Research, Inc | K202414 · 510(k) |
| 2020-12-29 | BriefCase | Aidoc Medical, Ltd. | K203508 · 510(k) |
| 2020-12-22 | AI Metrics | AI Metrics, LLC | K202229 · 510(k) |
| 2020-12-18 | EchoGo Pro | Ultromics Ltd | K201555 · 510(k) |
| 2020-12-10 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems Corporation | K203042 · 510(k) |
| 2020-12-10 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | GE Medical Systems, LLC | K201745 · 510(k) |
| 2020-12-07 | HepaFat-AI | Resonance Health Analysis Services Pty Ltd | K201039 · 510(k) |
| 2020-12-04 | HealthJOINT | Zebra Medical Vision Ltd. | K202487 · 510(k) |
| 2020-11-20 | Revolution Ascend | GE Healthcare Japan Corporation | K203169 · 510(k) |
| 2020-11-20 | CorInsights MRI | ADM Diagnostics, Inc. | K193287 · 510(k) |
| 2020-11-20 | HALO | NICo-Lab B.V. | K200873 · 510(k) |
| 2020-11-18 | Genius AI Detection | Hologic, Inc. | K201019 · 510(k) |
| 2020-11-18 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | K201195 · 510(k) |
| 2020-11-17 | PROView | GE Medical Systems SCS | K193306 · 510(k) |
| 2020-11-12 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | K193289 · 510(k) |
| 2020-11-06 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | K193562 · 510(k) |
| 2020-11-06 | Neuro.Al Algorithm | TeraRecon, Inc. | K200750 · 510(k) |
| 2020-10-30 | WRDensity by Whiterabbit.ai | Whiterabbit.ai Inc. | K202013 · 510(k) |
| 2020-10-30 | AutoContour | Radformation, Inc. | K200323 · 510(k) |
| 2020-10-16 | A View LCS | Coreline Soft Co., Ltd. | K201710 · 510(k) |
| 2020-10-15 | SIGNA 7.0T | GE Medical Systems, LLC | K201615 · 510(k) |
| 2020-10-11 | Quantib Prostate | Quantib BV | K202501 · 510(k) |
| 2020-10-02 | Cleerly Labs v2.0 | Cleerly, Inc. | K202280 · 510(k) |
| 2020-10-02 | LiverMultiScan | Perspectum LTD | K202170 · 510(k) |
| 2020-09-30 | THINQ | CorticoMetrics LLC | K192051 · 510(k) |
| 2020-09-29 | LVivo Seamless | DiA Imaging Analysis Ltd | K202546 · 510(k) |
| 2020-09-25 | Xeleris V Processing and Review Systems | GE Healthcare | K201103 · 510(k) |
| 2020-09-24 | RayStation | RaySearch Laboratories AB (publ) | K200569 · 510(k) |
| 2020-09-18 | Caption Guidance | Caption Health | K201992 · 510(k) |
| 2020-09-18 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | K200852 · 510(k) |
| 2020-09-16 | AVA (Augmented Vascular Analysis) | See-Mode Technologies Pte. Ltd. | K201369 · 510(k) |
| 2020-09-09 | Vivid iq | GE Medical Systems Ultrasound and | K200708 · 510(k) |
| 2020-09-09 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | K200851 · 510(k) |
| 2020-09-04 | SIGNA Artist | GE Healthcare (Tianjin) Company Limited | K202238 · 510(k) |
| 2020-08-26 | BriefCase | Aidoc Medical, Ltd. | K201020 · 510(k) |
| 2020-08-26 | AVIEW | Coreline Soft Co., Ltd | K200714 · 510(k) |
| 2020-08-14 | TOMTEC-ARENA | TOMTEC Imaging Systems GmbH | K201632 · 510(k) |
| 2020-08-13 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | K201444 · 510(k) |
| 2020-08-13 | Limbus Contour | Limbus AI Inc. | K201232 · 510(k) |
| 2020-08-07 | VIDAvision | VIDA Diagnostics Inc. | K200990 · 510(k) |
| 2020-08-07 | Accipiolx | MaxQ Al Ltd. | K201310 · 510(k) |
| 2020-08-04 | HYPER DLR | Shanghai United Imaging Healthcare Co., Ltd. | K193210 · 510(k) |
| 2020-07-30 | FractureDetect (FX) | Imagen Technologies, Inc. | K193417 · 510(k) |
| 2020-07-30 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA Inc. | K193283 · 510(k) |
| 2020-07-23 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and | K200743 · 510(k) |
| 2020-07-22 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | K200621 · 510(k) |
| 2020-07-16 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | K200497 · 510(k) |
| 2020-07-16 | HealthMammo | Zebra Medical Vision Ltd. | K200905 · 510(k) |
| 2020-07-14 | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K193097 · 510(k) |
| 2020-07-10 | AI-Rad Companion Engine | Siemens Medical Solutions USA, Inc. | K193294 · 510(k) |
| 2020-07-10 | Ezra Plexo Software | Ezra AI Inc. | K192969 · 510(k) |
| 2020-07-09 | Rapid LVO | iSchemaView Inc. | K200941 · 510(k) |
| 2020-07-06 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | K193073 · 510(k) |
| 2020-07-02 | Contour ProtegeAI | MIM Software Inc. | K193252 · 510(k) |
| 2020-07-02 | InferRead Lung CT.AI | Beijing Infervision Technology Co.,Ltd. | K192880 · 510(k) |
| 2020-06-26 | Rapid ASPECTS | iSchemaView Inc. | K200760 · 510(k) |
| 2020-06-24 | CINA | AVICENNA.AI | K200855 · 510(k) |
| 2020-06-23 | LVivo Software Application | DiA Imaging Analysis Ltd | K200232 · 510(k) |
| 2020-06-19 | BriefCase | Aidoc Medical, Ltd. | K193298 · 510(k) |
| 2020-06-17 | qER | Qure.ai Technologies | K200921 · 510(k) |
| 2020-06-17 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | K193290 · 510(k) |
| 2020-06-11 | MEDO ARIA | Medo.ai | K200356 · 510(k) |
| 2020-06-11 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | K200980 · 510(k) |
| 2020-06-03 | QLAB Advanced Quantification Software | Philips Healthcare | K200974 · 510(k) |
| 2020-06-01 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd | K192601 · 510(k) |
| 2020-05-14 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | K201034 · 510(k) |
| 2020-05-12 | HealthVCF | Zebra Medical Vision Ltd. | K192901 · 510(k) |
| 2020-05-05 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd | K193176 · 510(k) |
| 2020-05-05 | AVIEW LCS | Coreline Soft Co., Ltd | K193220 · 510(k) |
| 2020-05-01 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | Philips Ultrasound, Inc. | K201012 · 510(k) |
| 2020-04-21 | NinesAI | Nines, Inc. | K193351 · 510(k) |
| 2020-04-16 | Caption Guidance | Caption Health | K200755 · 510(k) |
| 2020-04-13 | CuraRad-ICH | CuraCloud Corp. | K192167 · 510(k) |
| 2020-04-10 | SIGNA Premier | GE Healthcare (GE Medical Systems, LLC) | K193282 · 510(k) |
| 2020-04-08 | AIMI-Triage CXR PTX | RADLogics, Inc. | K193300 · 510(k) |
| 2020-03-31 | Rapid ICH | iSchemaView Incorporated | K193087 · 510(k) |
| 2020-03-26 | KOSMOS | EchoNous, Inc. | K193518 · 510(k) |
| 2020-03-25 | Arterys MICA | Arterys Inc. | K192437 · 510(k) |
| 2020-03-25 | MammoScreen | Therapixel | K192854 · 510(k) |
| 2020-03-20 | Hepatic VCAR | GE Medical Systems SCS | K193281 · 510(k) |
| 2020-03-18 | Viz ICH | Viz.ai, Inc. | K193658 · 510(k) |
| 2020-03-16 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | K193267 · 510(k) |
| 2020-03-12 | SonoVision Ultrasound Imaging System | Tissue Differentiation Intelligence, LLC | K192388 · 510(k) |
| 2020-03-09 | syngo.CT Lung CAD | Siemens Medical Solutions, Inc | K193216 · 510(k) |
| 2020-03-09 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | K192574 · 510(k) |
| 2020-03-05 | Transpara | ScreenPoint Medical B.V. | K193229 · 510(k) |
| 2020-03-04 | Broncholab | Fluidda Inc. | K191550 · 510(k) |
| 2020-02-28 | icobrain-ctp | Icometrix NV | K192962 · 510(k) |
| 2020-02-28 | Red Dot | Behold.AI Technologies Limited | K191556 · 510(k) |
| 2020-02-28 | AccuContour | Xiamen Manteia Technology LTD. | K191928 · 510(k) |
| 2020-02-21 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | K192832 · 510(k) |
| 2020-02-19 | densitas densityai | Densitas, Inc. | K192973 · 510(k) |
| 2020-02-14 | Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutions USA, Inc | K193248 · 510(k) |
| 2020-02-13 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation | K192828 · 510(k) |
| 2020-02-12 | Biograph Horizon | Siemens Medical Solution USA, Inc. | K193178 · 510(k) |
| 2020-02-10 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | K192377 · 510(k) |
| 2020-02-07 | Caption Guidance | Bay Labs, Inc. | DEN190040 · De Novo |
| 2020-01-24 | MRCAT brain | Philips Medical Systems MR Finland | K193109 · 510(k) |
| 2020-01-16 | Auto Positioning | GE Hangwei Medical Systems, Co., Ltd. | K192956 · 510(k) |
| 2020-01-15 | ADAS 3D | Galgo Medical S.L | K191125 · 510(k) |
| 2019-12-20 | BriefCase | Aidoc Medical, Ltd. | K192383 · 510(k) |
| 2019-12-20 | QLAB Advanced Quantification Software | Philips Healthcare | K191647 · 510(k) |
| 2019-12-17 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | K192763 · 510(k) |
| 2019-12-13 | QyScore Software | Qynapse | K192531 · 510(k) |
| 2019-12-13 | Deep Learning Image Reconstruction | GE Healthcare Japan Corporation | K193170 · 510(k) |
| 2019-12-13 | Icobrain | Icometrix NV | K192130 · 510(k) |
| 2019-12-11 | NemoScan | Software Nemotec S.L. | K192571 · 510(k) |
| 2019-12-10 | Transpara | Screenpoint Medical B.V. | K192287 · 510(k) |
| 2019-12-07 | PhantomMSK Trauma | OrthoGrid Systems Inc. | K192279 · 510(k) |
| 2019-11-26 | HealthCXR | Zebra Medical Vision, Ltd. | K192320 · 510(k) |
| 2019-11-19 | RSI-MRI+ | MultiModal Imaging Services Corporation (dba HealthLytix) | K191278 · 510(k) |
| 2019-11-13 | EchoGo Core | Ultromics Ltd | K191171 · 510(k) |
| 2019-11-07 | MEDIP PRO | MEDICALIP Co., Ltd | K191026 · 510(k) |
| 2019-11-05 | Cleerly Labs | Cleerly Inc | K190868 · 510(k) |
| 2019-11-05 | KOALA | IB Lab GmbH | K192109 · 510(k) |
| 2019-10-18 | RTHawk, HeartVista Cardiac Package | HeartVista, Inc. | K183274 · 510(k) |
| 2019-10-17 | Merge PACS | Merge Healthcare Incorporated | K192455 · 510(k) |
| 2019-10-16 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics, Ltd. | K191493 · 510(k) |
| 2019-10-04 | ProFound AI Software V2.1 | iCAD Inc. | K191994 · 510(k) |
| 2019-10-04 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Omega Medical Imaging, LLC | K191713 · 510(k) |
| 2019-09-18 | Syngo.Via RT Image Suite | Siemens Medical Solutions USA, Inc. | K192065 · 510(k) |
| 2019-09-16 | SubtleMR | Subtle Medical, Inc. | K191688 · 510(k) |
| 2019-09-13 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | K192304 · 510(k) |
| 2019-09-10 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | K183268 · 510(k) |
| 2019-08-29 | D2P | 3D Systems, Inc. | K183489 · 510(k) |
| 2019-08-29 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | K192107 · 510(k) |
| 2019-08-12 | Critical Care Suite | GE Medical Systems, LLC. | K183182 · 510(k) |
| 2019-08-05 | aBSI | EXINI Diagnostics AB | K191262 · 510(k) |
| 2019-07-26 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | K183271 · 510(k) |
| 2019-07-12 | iNtuition-Structural Heart Module | TeraRecon Inc. | K191585 · 510(k) |
| 2019-07-10 | DeepCT | Deep01 Limited | K182875 · 510(k) |
| 2019-07-08 | RayCare 2.3 | RaySearch Laboratories AB (publ) | K191384 · 510(k) |
| 2019-07-05 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | K182901 · 510(k) |
| 2019-07-03 | Koios DS for Breast | Koios Medical, Inc. | K190442 · 510(k) |
| 2019-06-27 | LiverMultiScan (LMSv3) | Perspectum Diagnostics Ltd | K190017 · 510(k) |
| 2019-06-19 | RayStation | RaySearch Laboratories AB (publ) | K190387 · 510(k) |
| 2019-06-13 | ClariCT.AI | ClariPI Inc. | K183460 · 510(k) |
| 2019-06-13 | HealthICH | Zebra Medical Vision Ltd. | K190424 · 510(k) |
| 2019-06-12 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems Corporation | K183046 · 510(k) |
| 2019-05-31 | BriefCase | Aidoc Medical, Ltd. | K190896 · 510(k) |
| 2019-05-13 | SurgicalAR | MEDIVIS, Inc. | K190764 · 510(k) |
| 2019-05-06 | HealthPNX | Zebra Medical Vision Ltd. | K190362 · 510(k) |
| 2019-04-18 | Lung Vision System | Body Vision Medical Ltd. | K183593 · 510(k) |
| 2019-04-15 | BriefCase | Aidoc Medical, Ltd. | K190072 · 510(k) |
| 2019-04-12 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | K183202 · 510(k) |
| 2019-04-08 | Bone VCAR (BVCAR) | GE Medical Systems SCS | K183204 · 510(k) |
| 2019-03-19 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | K183019 · 510(k) |
| 2019-03-08 | cmTriage | CureMetrix, Inc | K183285 · 510(k) |
| 2019-02-01 | AI Rad Companion (Engine) | Siemens Medical Solutions USA, Inc. | K183272 · 510(k) |
| 2019-01-18 | SIGNA Premier | GE Medical Systems, LLC | K183231 · 510(k) |
| 2019-01-09 | MRCP+ v1.0 | Perspectum Diagnostics Ltd | K183133 · 510(k) |
| 2018-12-28 | AmCAD-UO | AmCad BioMed Corporation | K180867 · 510(k) |
| 2018-12-27 | Quantib ND | Quantib BV | K182564 · 510(k) |
| 2018-12-27 | iSchemaView RAPID | iSchemaView, Inc. | K182130 · 510(k) |
| 2018-12-21 | vascuCAP | Elucid Bioimaging Inc. | K183012 · 510(k) |
| 2018-12-14 | Centricity Universal Viewer | GE Healthcare | K182419 · 510(k) |
| 2018-12-06 | PowerLook Tomo Detection V2 Software | iCAD Inc. | K182373 · 510(k) |
| 2018-12-06 | AMRA Profiler | AMRA Medical AB | K173749 · 510(k) |
| 2018-11-30 | FerriSmart Analysis System | Resonance Health Analysis Services Pty Ltd | K182218 · 510(k) |
| 2018-11-30 | SubtlePET | Subtle Medical, Inc. | K182336 · 510(k) |
| 2018-11-21 | Transpara | ScreenPoint Medical BV | K181704 · 510(k) |
| 2018-11-20 | Vitrea CT Brain Perfusion | Vital Images, Inc. | K181247 · 510(k) |
| 2018-11-06 | icobrain | icometrix NV | K181939 · 510(k) |
| 2018-11-02 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | NinePoint Medical, Inc. | K182616 · 510(k) |
| 2018-10-26 | Accipiolx | MaxQ-Al Ltd. | K182177 · 510(k) |
| 2018-10-25 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K181685 · 510(k) |
| 2018-10-17 | Arterys MICA | Arterys Inc. | K182034 · 510(k) |
| 2018-10-09 | Ziostation2 | Ziosoft, Inc. | K181892 · 510(k) |
| 2018-09-21 | Volpara Imaging Software | Volpara Health Technologies Limited | K182310 · 510(k) |
| 2018-08-01 | BriefCase | Aidoc Medical, Ltd. | K180647 · 510(k) |
| 2018-07-23 | Quantitative Total Extensible Imaging (QTxI) | AIQ Solutions, Inc. | K173444 · 510(k) |
| 2018-07-10 | Uscan | EchoNous, Inc. | K181574 · 510(k) |
| 2018-07-10 | Workflow Box | Mirada Medical Ltd. | K181572 · 510(k) |
| 2018-06-26 | DenSeeMammo | Statlife | K173574 · 510(k) |
| 2018-06-14 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | K173780 · 510(k) |
| 2018-06-13 | HealthCCS | Zebra Medical Vision Ltd. | K172983 · 510(k) |
| 2018-06-05 | LungQ Software | Thirona Corporation | K173821 · 510(k) |
| 2018-05-24 | OsteoDetect | Imagen Technologies, Inc. | DEN180005 · De Novo |
| 2018-05-14 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | K180799 · 510(k) |
| 2018-05-14 | Ventripoint Medical System Plus (VMS+) | Ventripoint Diagnostics, Ltd. | K173810 · 510(k) |
| 2018-05-02 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics, | K180599 · 510(k) |
| 2018-04-20 | Viz CTP | Viz.ai, Inc. | K180161 · 510(k) |
| 2018-04-05 | DR 800 with MUSICA Dynamic | Agfa HealthCare N.V. | K180589 · 510(k) |
| 2018-03-09 | Quantib Brain | Quantib BV | K173939 · 510(k) |
| 2018-03-08 | iQMR | Medic Vision - Imaging Solutions Ltd | K173605 · 510(k) |
| 2018-02-23 | DM-Density | Densitas, Inc. | K170540 · 510(k) |
| 2018-02-13 | ContaCT | Viz.Al, Inc. | DEN170073 · De Novo |
| 2018-02-08 | UNiD Spine Analyzer | Medicrea International | K180091 · 510(k) |
| 2018-01-25 | Arterys Oncology DL | Arterys Inc. | K173542 · 510(k) |
| 2018-01-12 | Illumeo System | Philips Medical Systems Technologies, Ltd. | K173588 · 510(k) |
| 2018-01-08 | cNeuro cMRI | Combinostics Oy | K171328 · 510(k) |
| 2017-12-27 | Radiomics App v1.0 | Microsoft Corp. | K173420 · 510(k) |
| 2017-10-27 | Infinitt PACS 7.0 | Infinitt Healthcare Co.,Ltd. | K172803 · 510(k) |
| 2017-10-20 | Quantra | HOLOGIC, INC. | K163623 · 510(k) |
| 2017-09-15 | BladderScan Prime PLUS System | Verathon Incorporated | K172356 · 510(k) |
| 2017-09-14 | Clarius Ultrasound System | Clarius Mobile Health Corp. | K172385 · 510(k) |
| 2017-09-07 | NeuroQuant | CorTechs Labs, Inc | K170981 · 510(k) |
| 2017-07-19 | QuantX | Quantitative Insights, Inc | DEN170022 · De Novo |
| 2017-06-09 | syngo Application Software | Siemens Medical Solutions, USA, Inc. | K170747 · 510(k) |
| 2017-06-07 | SmartTarget | SmartTarget, Ltd. | K170250 · 510(k) |
| 2017-05-24 | UNiD Spine Analyzer | MEDICREA INTERNATIONAL | K170172 · 510(k) |
| 2017-05-11 | Lung Vision | BODY VISION MEDICAL LTD. | K163622 · 510(k) |
| 2017-04-26 | AmCAD-UV | AmCad BioMed Corporation | K170069 · 510(k) |
| 2017-03-24 | PowerLook® Tomo Detection Software | iCAD Inc | P160009 · PMA |
| 2017-02-14 | SIS Software | Surgical Information Sciences, Inc. | K162830 · 510(k) |
| 2017-01-06 | Quantib Brain 1.2 | Quantib BV | K163013 · 510(k) |
| 2017-01-05 | Arterys Cardio DL | ARTERYS INC. | K163253 · 510(k) |
| 2016-12-28 | ClearView cCAD | ClearView Diagnostics Inc. | K161959 · 510(k) |
| 2016-12-07 | CT CoPilot | ZEPMED, LLC. | K161322 · 510(k) |
| 2016-11-30 | Clarius Ultrasound System | Clarius Mobile Health Corp. | K163138 · 510(k) |
| 2016-11-09 | QVCAD System | QView Medical, Inc. | P150043 · PMA |
| 2016-09-19 | PixelShine | ALGOMEDICA | K161625 · 510(k) |
| 2016-09-09 | ClearRead CT | RIVERAIN TECHNOLOGIES, LLC | K161201 · 510(k) |
| 2016-08-09 | icobrain | Icometrix | K161148 · 510(k) |
| 2016-07-28 | LVivo Software Application | DIACARDIO, LTD. | K161382 · 510(k) |
| 2016-07-07 | Cydar EV | Cydar Ltd. | K160088 · 510(k) |
| 2016-06-17 | Quantib Brain 1 | QUANTIB BV | K153351 · 510(k) |
| 2016-01-07 | Volpara Imaging Software | Matakina Technology LTD | K153427 · 510(k) |
| 2015-02-27 | IRIS INTELLIGENT RETINAL IMAGING SYSTEM | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | K141922 · 510(k) |
| 2014-10-10 | QUANTRA | HOLOGIC, INC. | K142037 · 510(k) |
| 2014-09-17 | Lung Density Analysis | IMBIO LLC | K141069 · 510(k) |
| 2014-08-22 | CVI42 | CIRCLE CARDIOVASCULAR IMAGING INC | K141480 · 510(k) |
| 2014-04-22 | HEPATIC VCAR | GE MEDICAL SYSTEMS SCS | K133649 · 510(k) |
| 2014-01-24 | YSIO MAX | SIEMENS MEDICAL SOLUTIONS USA, INC. | K133259 · 510(k) |
| 2012-12-27 | CLEARREAD +CONFIRM | RIVERAIN TECHNOLOGIES | K123526 · 510(k) |
| 2012-04-13 | ALPHAPOINT IMAGING SOFTWARE | RADLOGICS, INC. | K120161 · 510(k) |
| 2011-12-28 | DELTAVIEW MODEL 2.1 | RIVERAIN MEDICAL GROUP,LLC | K111776 · 510(k) |
| 2008-09-12 | QUANTRA | HOLOGIC, INC. | K082483 · 510(k) |
| 2008-05-15 | IB NEURO, VERSION 1.0 | IMAGING BIOMETRICS, LLC | K080762 · 510(k) |
| 2002-01-31 | SECOND LOOK ™ | ICAD, INC. | P010034 · PMA |
| 2001-07-12 | RAPIDSCREEN RS-2000 | RIVERAIN MEDICAL GROUP | P000041 · PMA |
| 1998-09-02 | LOGICON CARIES DETECTOR | CARESTREAM DENTAL LLC | P980025 · PMA |
| 1998-06-26 | M1000 IMAGECHECKER | Hologic, Inc. | P970058 · PMA |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.