510(k) K260898 ยท QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Transpara (2.1.0)
| Applicant | Screenpoint Medical B.V., Nijmegen, NL |
| Decision | Substantially Equivalent, Aug 14, 2026 |
| Received | Mar 18, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260898
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.