510(k) K230197 ยท QIH Automated Radiological Image Processing Software
BoneMRI v1.6
| Applicant | Mriguidance B.V., Utrecht, NL |
| Decision | Substantially Equivalent, Feb 22, 2023 |
| Received | Jan 25, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230197
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.