510(k) K253682 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
DeepHealth ProstateAI
| Applicant | Quantib B.V., Rotterdam, NL |
| Decision | Substantially Equivalent, Apr 29, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253682
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.