DeepXray Spina— 510(k) K253192
Substantially EquivalentAlpha Intelligence Manifolds, Inc.
FDA 510(k) clearance K253192 for DeepXray Spina, Substantially Equivalent on 2026-06-10. Applicant: Alpha Intelligence Manifolds, Inc.. Device class: 2.
Summary
Alpha Intelligence Manifolds' DeepXray Spina is filed under SAO, radiology software for opportunistic evaluation of low bone mineral density. The record doesn't describe the software beyond its name and the code name.
Class II, 21 CFR 892.1171. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Alpha Intelligence Manifolds filed from New Taipei City, Taiwan. The decision came 257 calendar days after receipt (September 26, 2025 to June 10, 2026).
Clearance details
- Applicant
- Alpha Intelligence Manifolds, Inc.
- Product code
- Product code SAO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1171
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Recent devices under product code SAO
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