510(k) K253835 ยท QIH Automated Radiological Image Processing Software
Affinity
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Dec 1, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253835
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.