510(k) K243294 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Brainomix 360 e-ASPECTS
| Applicant | Brainomix Limited, Oxford, GB |
| Decision | Substantially Equivalent, Feb 14, 2025 |
| Received | Oct 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243294
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.