510(k) K192287 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Transpara
| Applicant | Screenpoint Medical B.V., Nijmegen, NL |
| Decision | Substantially Equivalent, Dec 10, 2019 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192287
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.