510(k) K251527 ยท QIH Automated Radiological Image Processing Software
Brain WMH
| Applicant | Quantib B.V., Rotterdam, NL |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | May 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251527
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.