510(k) K260324 ยท QIH Automated Radiological Image Processing Software
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
| Applicant | Canon Medical Informatics, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260324
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.