FDA Product Code
FDA Product Code SAO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1171
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253192 | DeepXray Spina | Alpha Intelligence Manifolds, Inc. | 2026-06-10 | Traditional | PDF ↗ |
| K251408 | OsteoSight Hip (v1) | Naitive Technologies, Ltd. | 2025-09-02 | Traditional | PDF ↗ |
| DEN230023 | Rho | 16 Bit, Inc. | 2024-04-09 | Direct | — |
Product code SAO · Class II · Radiology. Data: openFDA.