510(k) K221347 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Transpara 1.7.2
| Applicant | Screenpoint Medical B.V., Nijmegen, NL |
| Decision | Substantially Equivalent, Aug 3, 2022 |
| Received | May 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221347
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.