OsteoSight™ Hip (v1) is an AI-enabled medical device from Naitive Technologies Ltd, listed by FDA (510(k), K251408) with a decision date of 2025-09-02. Review panel: Radiology.
| FDA submission number | K251408 |
|---|---|
| Pathway | 510(k) |
| Company | Naitive Technologies Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-09-02 |
| Decision | Substantially Equivalent |
| Product code | SAO |
| Classification | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device class | 2 |
| Regulation number | 892.1171 |
| Review time (calendar days) | 119 |
| Applicant country | GB |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.