510(k) K261352 ยท LLZ System, Image Processing, Radiological
2D Hip Planning Software
| Applicant | One Ortho, Saint-Genis-Laval, FR |
| Decision | Substantially Equivalent, Jun 8, 2026 |
| Received | Apr 24, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261352
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.