DeepXray Spina
FDA 510(k) clearance K253192 · decided 2026-06-10
Clearance details
- K-number
- K253192
- Device name
- DeepXray Spina
- Applicant
- Alpha Intelligence Manifolds, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-06-10
- Days to decision
- 257 days
- Clearance type
- Traditional
- Product code
- SAO
- Device class
- 2
- Regulation number
- 892.1171
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OsteoSightâ„¢ Hip (v1) (K251408) | Naitive Technologies, Ltd. | 2025-09-02 |
| Rho (DEN230023) | 16 Bit, Inc. | 2024-04-09 |
Recalls involving this device
No recalls on record reference this clearance.