OsteoSight Spine analyses standard frontal lumbar, thoracic or chest radiographs in patients aged 50 and over and alerts the reporting doctor to possible low L1–L4 bone mineral density, prompting a bone health work-up. It does not replace DXA and a missing report does not rule out low bone density.
- Type
- FDA decision
- Company
- Naitive Technologies (UK)
- Device
- OsteoSight Spine (v1)
- Date
- 27 October 2026
- Jurisdiction
- US
- Classification
- 510(k) K261512 (SAO)
- Source
- FDA 510(k) database
Official source →Source checked