510(k) K252294 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Fetal EchoScan (v1.2)
| Applicant | Brightheart, Paris, FR |
| Decision | Substantially Equivalent, Dec 8, 2025 |
| Received | Jul 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252294
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.