510(k) K251022 ยท KGI Densitometer, Bone
3D-SHAPER
| Applicant | 3D-Shaper Medical S.L, Barcelona, ES |
| Decision | Substantially Equivalent, Sep 5, 2025 |
| Received | Apr 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251022
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.