| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| POK | — | — | — | 3 | 2025-12-08 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 2 | 2025-06-05 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-08 | K252294 | Fetal EchoScan (v1.2) | POK | — | — |
| 2025-06-05 | K251456 | BrightHeart View Classifier | QIH | Class II | Radiology |
| 2025-05-07 | K243684 | BrightHeart View Classifier | QIH | Class II | Radiology |
| 2025-05-02 | K251071 | Fetal EchoScan (v1.1) | POK | — | — |
| 2024-11-14 | K242342 | Fetal EchoScan | POK | — | — |