510(k) K243679 · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
MammoScreen® (4)
| Applicant | Therapixel, Nice, FR |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243679
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.