510(k) K251071 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Fetal EchoScan (v1.1)
| Applicant | Brightheart, Paris, FR |
| Decision | Substantially Equivalent, May 2, 2025 |
| Received | Apr 7, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251071
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.