Clearance Summary
BoneVue received FDA 510(k) clearance under submission number K254072, sponsored by Curvebeam AI / Curvebeam, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-09-11.
- Submission: K254072
- Applicant / Sponsor: Curvebeam AI / Curvebeam, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2026-09-11
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.