Fetal EchoScan (v1.2) is an AI-enabled medical device from Brightheart, listed by FDA (510(k), K252294) with a decision date of 2025-12-08. Review panel: Radiology.
| FDA submission number | K252294 |
|---|---|
| Pathway | 510(k) |
| Company | Brightheart |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-12-08 |
| Decision | Substantially Equivalent |
| Product code | POK |
| Classification | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | 2 |
| Regulation number | 892.2060 |
| Review time (calendar days) | 138 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
More devices from Brightheart · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.