510(k) K260406 ยท QIH Automated Radiological Image Processing Software
Brainomix 360 Hyperdensity
| Applicant | Brainomix Limited, Oxford, GB |
| Decision | Substantially Equivalent, Jun 12, 2026 |
| Received | Feb 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260406
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.