510(k) K254072 ยท KGI Densitometer, Bone
BoneVue
| Applicant | Curvebeam AI / Curvebeam, LLC, Hatfield PA, US |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Dec 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254072
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.