SAO
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1171
- Medical specialty
- Radiology
- FDA definition
- This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.
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| Record | Firm | Date |
|---|---|---|
| DeepXray Spina (K253192) | Alpha Intelligence Manifolds, Inc. | 2026-06-10 |
| OsteoSightâ„¢ Hip (v1) (K251408) | Naitive Technologies, Ltd. | 2025-09-02 |
| Rho (DEN230023) | 16 Bit, Inc. | 2024-04-09 |
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Every clearance here is in the API, with alerts when new ones post.