510(k) K250023 ยท QIH Automated Radiological Image Processing Software
SMART PCFD
| Applicant | Disior, Ltd., Helsinki Uusimaa, FI |
| Decision | Substantially Equivalent, Sep 29, 2025 |
| Received | Jan 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250023
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.