| Koios DS (3.8) (K253884) | Koios Medical, Inc. | 2026-07-02 |
| Sonio Suspect (K261519) | Sonio | 2026-06-04 |
| Automated Aortic Stenosis Software (AutoAS) (K254161) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 |
| RevealAI-Lung (K251769) | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 |
| Fetal EchoScan (v1.2) (K252294) | Brightheart | 2025-12-08 |
| StrokeSENS ASPECTS Software Application (K250221) | Circle Cardiovascular Imaging, Inc. | 2025-07-01 |
| Fetal EchoScan (v1.1) (K251071) | Brightheart | 2025-05-02 |
| Sonio Suspect (K243614) | Sonio | 2025-02-21 |
| Brainomix 360 e-ASPECTS (K243294) | Brainomix Limited | 2025-02-14 |
| Koios DS (K242130) | Koios Medical, Inc. | 2024-11-15 |
| Fetal EchoScan (K242342) | Brightheart | 2024-11-14 |
| EchoSolv AS (K241245) | Echo IQ, Ltd. | 2024-10-04 |
| AISAP Cardio V1.0 (K234141) | Aisap | 2024-08-01 |
| CINA-ASPECTS (K233342) | Avicenna.Ai | 2024-03-15 |
| Rapid ASPECTS (v3) (K232156) | Ischemaview, Inc. | 2024-01-19 |
| Brainomix 360 e-ASPECTS (K221564) | Brainomix Limited | 2023-02-23 |
| Avenda Health AI Prostate Cancer Planning Software (K221624) | Avenda Health, Inc. | 2022-11-22 |
| Koios DS (K212616) | Koios Medical, Inc. | 2021-12-16 |
| Optellum Virtual Nodule Clinic, Optellum software, Optellum platform (K202300) | Optellum, Ltd. | 2021-03-05 |
| EchoGo Pro (K201555) | Ultromics, Ltd. | 2020-12-18 |
| Rapid ASPECTS (K200760) | Ischemaview, Inc. | 2020-06-26 |
| Koios DS for Breast (K190442) | Koios Medical, Inc. | 2019-07-03 |
| QuantX (DEN170022) | Quantitative Insights, Inc. | 2017-07-19 |