Tool · Updated weekly from the FDA
AI Medical Device Tracker
Search all 1,614 AI-enabled medical devices the US FDA has authorised, by device, company or specialty. Data from the FDA's official list, last downloaded 2026-11-05.
1,614AI devices authorised
181decisions in 2026 so far
76%in radiology
61via De Novo or PMA
By specialty
Radiology (1230)Cardiology (154)Neurology (73)Anesthesiology (30)Gastroenterology-Urology (27)Hematology (22)Pathology (10)Ophthalmology (eye care) (10)Surgery (9)Clinical Chemistry (9)Orthopedics (8)Dental (7)Microbiology (7)General Hospital (6)Obstetrics and Gynecology (5)Clinical Toxicology (5)Ear Nose & Throat (1)Immunology (1)
Authorisations per year
Companies with the most AI devices
| Company | Devices |
|---|---|
| Siemens Medical Solutions USA, Inc. | 56 |
| Canon Medical Systems Corporation | 42 |
| Aidoc Medical, Ltd. | 30 |
| Shanghai United Imaging Healthcare Co., Ltd. | 29 |
| Philips Ultrasound LLC | 14 |
| Siemens Healthcare GmbH | 13 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics | 13 |
| Samsung Medison Co., Ltd. | 13 |
| GE Medical Systems, LLC | 13 |
| Clarius Mobile Health Corp. | 12 |
Latest 50 decisions
| Decision date | Device | Company | Specialty | FDA record |
|---|---|---|---|---|
| 2026-06-29 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | Radiology | K253628 · 510(k) |
| 2026-06-29 | ADAS 3D | Adas3D Medical S.L. | Radiology | K253969 · 510(k) |
| 2026-06-29 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | K260667 · 510(k) |
| 2026-06-27 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | Neurology | K253390 · 510(k) |
| 2026-06-26 | MammoScreen® (5) | Therapixel | Radiology | K260714 · 510(k) |
| 2026-06-25 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | Radiology | K253786 · 510(k) |
| 2026-06-24 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | Radiology | K253560 · 510(k) |
| 2026-06-22 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | Anesthesiology | K253148 · 510(k) |
| 2026-06-22 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | Radiology | K260316 · 510(k) |
| 2026-06-18 | RadOncAI | Informai | Radiology | K253050 · 510(k) |
| 2026-06-18 | ARTHUR | ROPCA ApS | Radiology | K260190 · 510(k) |
| 2026-06-18 | Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health | Radiology | K260729 · 510(k) |
| 2026-06-18 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | Radiology | 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. | Radiology | K260844 · 510(k) |
| 2026-06-15 | MediAI-OA | Crescom Co., Ltd. | Radiology | K253172 · 510(k) |
| 2026-06-15 | LungMaps | Siemens Healthineers AG | Radiology | K253690 · 510(k) |
| 2026-06-15 | Saige-Dx | DeepHealth, Inc. | Radiology | K253825 · 510(k) |
| 2026-06-15 | WatchMate Software | Anumana, Inc. | Radiology | K260300 · 510(k) |
| 2026-06-12 | Brainomix 360 Hyperdensity | Brainomix Limited | Radiology | K260406 · 510(k) |
| 2026-06-11 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | Radiology | K260322 · 510(k) |
| 2026-06-10 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | Radiology | K253192 · 510(k) |
| 2026-06-08 | EchoNext | Pathwai, Inc. | Cardiology | K260332 · 510(k) |
| 2026-06-04 | Instrument Exit Point on Touch Surgery Aide | Covidien, LLC | Gastroenterology-Urology | K253984 · 510(k) |
| 2026-06-04 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | Radiology | K260497 · 510(k) |
| 2026-06-04 | Sonio Suspect | Sonio | Radiology | K261519 · 510(k) |
| 2026-06-03 | MeRT System | Wave Neuroscience | Neurology | K260402 · 510(k) |
| 2026-06-03 | HeartFocus | Deski | Radiology | K260780 · 510(k) |
| 2026-06-02 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | Anesthesiology | K252844 · 510(k) |
| 2026-05-29 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | Cardiology | K252859 · 510(k) |
| 2026-05-29 | HistoSonics® Planning Tool | HistoSonics, Inc. | Radiology | K252947 · 510(k) |
| 2026-05-29 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | Radiology | K260077 · 510(k) |
| 2026-05-29 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | Gastroenterology-Urology | K261369 · 510(k) |
| 2026-05-28 | ANDI 2.2 | Imeka Solutions, Inc. | Radiology | K261405 · 510(k) |
| 2026-05-27 | Synapse Lung Nodule AI | Fujifilm Corporation | Radiology | K254075 · 510(k) |
| 2026-05-27 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Radiology | K260123 · 510(k) |
| 2026-05-27 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | Radiology | K260680 · 510(k) |
| 2026-05-22 | PCWP Analysis Software | Cardiosense, Inc. | Cardiology | DEN250057 · De Novo |
| 2026-05-22 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | Radiology | K260113 · 510(k) |
| 2026-05-22 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | Radiology | 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 | Radiology | K253720 · 510(k) |
| 2026-05-21 | BAC | DeepHealth, Inc. | Radiology | K254131 · 510(k) |
| 2026-05-21 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | Radiology | K260234 · 510(k) |
| 2026-05-21 | DeepView AI® System | spectralmd, inc. | Surgery | DEN250028 · De Novo |
| 2026-05-20 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | Radiology | K253596 · 510(k) |
| 2026-05-15 | Embryo Predict | Alife Health | Obstetrics and Gynecology | K250781 · 510(k) |
| 2026-05-15 | Neurophet SCALE PET | Neurophet., Inc. | Radiology | 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 | Radiology | K253716 · 510(k) |
| 2026-05-15 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | Radiology | K254120 · 510(k) |
| 2026-05-15 | Neurophet AQUA | Neurophet., Inc. | Radiology | K261273 · 510(k) |
| 2026-05-15 | UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | Radiology | K261289 · 510(k) |
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: U.S. Food and Drug Administration, Artificial Intelligence-Enabled Medical Devices list. We copy the list as published and link each entry to its FDA record. It is information only, not a recommendation of any device.