510(k) K210404 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Transpara 1.7.0
| Applicant | Screenpoint Medical B.V., Nijmegen, NL |
| Decision | Substantially Equivalent, Jun 2, 2021 |
| Received | Feb 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210404
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.