DeepXray Spina— 510(k) K253192

Name: FDA 510(k) clearance K253192
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Substantially Equivalent

Alpha 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.

Clearance details

Applicant: Alpha Intelligence Manifolds, Inc.
Product code: Code SAO
Device class: Class 2
Regulation: 21 CFR 892.1171
Advisory panel: Radiology
Date received: 2025-09-26
Decision date: 2026-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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