510(k) K261500 ยท LLZ System, Image Processing, Radiological
KBA3D (v2.4.0)
| Applicant | S.M.A.I.O, Saint-Priest, FR |
| Decision | Substantially Equivalent, Aug 17, 2026 |
| Received | May 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261500
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.