510(k) clearance
OsteoSight Spine (v1)
- 510(k) number
- K261512
- Applicant
- Naitive Technologies, Ltd.
- Decision date
- Oct 27, 2026
- Date received
- May 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SAO
- Device type
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Device class
- Class II
- Regulation
- 21 CFR 892.1171
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Cambridge, GB