510(k) K261535 ยท QIH Automated Radiological Image Processing Software
Hi-D Imaging 4TAVR
| Applicant | Hi-D Imaging AG, Winterthur, CH |
| Decision | Substantially Equivalent, Jul 20, 2026 |
| Received | May 8, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261535
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.