510(k) K221426 ยท LLZ System, Image Processing, Radiological
Functional MR V1.0
| Applicant | Olea Medical S.A.S., La Ciotat, FR |
| Decision | Substantially Equivalent, Jul 6, 2022 |
| Received | May 16, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2023 | OLEA MEDICAL Functional MR V1.0 Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.