510(k) DEN240047

Allix5 by Clairity, Inc. — Product Code SEZ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 30, 2025
Date Received: September 6, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Radiological Software Device To Predict Future Breast Cancer Risk
Device Class: Class II
Regulation Number: 892.8500
Review Panel: RA
Submission Type

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 patients 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.