510(k) clearance
BoneVue
- 510(k) number
- K254072
- Applicant
- Curvebeam AI / Curvebeam, LLC
- Decision date
- Sep 11, 2026
- Date received
- Dec 18, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KGI
- Device type
- Densitometer, Bone
- Device class
- Class II
- Regulation
- 21 CFR 892.1170
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hatfield, PA, US