AI Device Tracker / Hematology
FDA-authorised AI devices in hematology
22 AI-enabled devices with hematology as the lead FDA review panel, newest first. First in this list: 2001; most recent: 2026-04-09.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-04-09 | Seaman Pro/Seaman | Checkcells, Inc. | K252228 · 510(k) |
| 2026-02-06 | Athelas Home | Athelas, Inc. | K243348 · 510(k) |
| 2025-06-27 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | K243144 · 510(k) |
| 2025-05-30 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., LTD. | K242830 · 510(k) |
| 2025-05-09 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., LTD. | K242388 · 510(k) |
| 2024-05-03 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray Inc. | K232416 · 510(k) |
| 2023-09-19 | AI100 with Shonit | SigTuple Technologies Pvt. Ltd. | K221309 · 510(k) |
| 2022-05-03 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | K220013 · 510(k) |
| 2022-03-22 | Athelas Home | Athelas Inc. | K200828 · 510(k) |
| 2020-10-28 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | K202089 · 510(k) |
| 2020-10-16 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | K200595 · 510(k) |
| 2020-10-02 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs LTD. | K201301 · 510(k) |
| 2019-11-01 | Sight OLO | Sight Diagnostics Ltd. | K190898 · 510(k) |
| 2018-11-16 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | K180343 · 510(k) |
| 2018-11-05 | Athelas One | Athelas Inc. | K181288 · 510(k) |
| 2017-08-01 | Advanced RBC Application | Cella Vision AB | K171315 · 510(k) |
| 2013-03-22 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | BECKMAN COULTER, INC. | K120771 · 510(k) |
| 2011-09-16 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CELLAVISION AB | K102778 · 510(k) |
| 2010-05-12 | EASYCELL CELL LOCATOR | MEDICA CORP. | K092116 · 510(k) |
| 2008-12-05 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CELLAVISION AB | K080595 · 510(k) |
| 2004-02-10 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | K033840 · 510(k) |
| 2001-03-15 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | K003301 · 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: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.