510(k) K260584 ยท QIH Automated Radiological Image Processing Software
BoneMRI
| Applicant | Mriguidance B.V., Utrecht, NL |
| Decision | Substantially Equivalent, Aug 21, 2026 |
| Received | Feb 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260584
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.