Not Cleared Direct

DEN240047 - Allix5 (FDA 510(k) Clearance)

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

DEN240047 is an FDA 510(k) submission for the Allix5. This device is classified as a Radiological Software Device To Predict Future Breast Cancer Risk (Class II - Special Controls, product code SEZ).

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

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.8500. 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..

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 -

Device Classification

Product Code SEZ - Radiological Software Device To Predict Future Breast Cancer Risk
Device Class Class II - 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.