Brightheart
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories2
Latest FDA decision2025-12-08
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252294 | Fetal EchoScan (v1.2) | POK | 2025-12-08 | View |
| 510(k) | K251456 | BrightHeart View Classifier | QIH | 2025-06-05 | View |
| 510(k) | K243684 | BrightHeart View Classifier | QIH | 2025-05-07 | View |
| 510(k) | K251071 | Fetal EchoScan (v1.1) | POK | 2025-05-02 | View |
| 510(k) | K242342 | Fetal EchoScan | POK | 2024-11-14 | View |
No matching devices.