510(k) K261289 · QIH Automated Radiological Image Processing Software
UNiD Spine Analyzer (SW3002)
| Applicant | Medicrea International S.A.S. (Medtronic), Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Apr 20, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261289
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.