510(k) K243681 ยท LLZ System, Image Processing, Radiological
Neuro Insight V1.0
| Applicant | Olea Medical S.A.S., La Ciotat, FR |
| Decision | Substantially Equivalent, Jul 23, 2025 |
| Received | Nov 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243681
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.