Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Regulation 892.1171
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SAO
| Company | 510(k)s | Recalls |
|---|---|---|
| 16 Bit, Inc. | 1 | 0 |
| Alpha Intelligence Manifolds, Inc. | 1 | 0 |
| Naitive Technologies, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2026 | K253192 | DeepXray Spina Alpha Intelligence Manifolds, Inc., TW | SAO |
| Sep 2, 2025 | K251408 | OsteoSight Hip (v1) Naitive Technologies, Ltd., GB | SAO |
| Apr 9, 2024 | DEN230023 | Rho 16 Bit, Inc., CA | SAO |
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