510(k) K242342 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Fetal EchoScan
| Applicant | Brightheart, Paris, FR |
| Decision | Substantially Equivalent, Nov 14, 2024 |
| Received | Aug 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242342
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.