Cleared Traditional

DeepXray Spina (K253192) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253192 · Alpha Intelligence Manifolds, Inc. · Radiology device
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Jun 2026
Decision
257d
Days
Class 2
Risk

K253192 is an FDA 510(k) clearance for the DeepXray Spina. Classified as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (product code SAO), Class II - Special Controls.

Submitted by Alpha Intelligence Manifolds, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on June 10, 2026 after a review of 257 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1171 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alpha Intelligence Manifolds, Inc. devices

Submission Details

510(k) Number K253192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2025
Decision Date June 10, 2026
Days to Decision 257 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 107d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1171
Definition This Device Is Software Which Opportunistically Assesses Radiological Images To Estimate Bone Mineral Density (bmd) Intended To Assist In A Healthcare Professional's Decision To Evaluate Patients For Possible Low Bmd Within A Bone Health Screening Program. The Software Employs An Algorithm That Estimates Bmd Using Eligible Radiological Image Data Obtained For Other Clinical Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.