Not Cleared Direct

DEN240047 - Allix5 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240047 · Clairity, Inc. · Radiology device
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May 2025
Decision
266d
Days
Class 2
Risk

DEN240047 is an FDA 510(k) submission (not cleared) for the Allix5. Classified as Radiological Software Device To Predict Future Breast Cancer Risk (product code SEZ), Class II - Special Controls.

Submitted by Clairity, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on May 30, 2025 after a review of 266 days.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.8500 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 266 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Clairity, Inc. devices

Submission Details

510(k) Number DEN240047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 06, 2024
Decision Date May 30, 2025
Days to Decision 266 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 107d · This submission: 266d
Pathway characteristics

Device Classification

Product Code SEZ Radiological Software Device To Predict Future Breast Cancer Risk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.8500
Definition A Radiological Software Device To Predict Future Breast Cancer Risk Is A Device That Analyzes Radiological Images Generated By Breast Imaging Modalities And/or Inputs Derived From Radiological Images To Provide Qualified Healthcare Professionals With A Prediction Of The Risk Of Future (incident) Breast Cancer. This Device Produces A Numeric Probability And/or Risk Category Indicative Of The Patient’s Future Breast Cancer Risk From The Time The Analyzed Images Were Acquired. This Device Is Not Intended To Diagnose, Detect, Or Inform The Treatment Of Cancer. The Output Of This Device Is Not Intended To Guide Interpretation Of Imaging Exams.
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.