DeviceClearance

Product code SEZ— Radiology

Allix5

Classification name
Radiological Software Device To Predict Future Breast Cancer Risk
Device class
Class 2
Regulation
21 CFR 892.8500
Advisory panel
Radiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SEZ under 21 CFR 892.8500, via openFDA

Market context for product code SEZ

FDA has cleared 1 device under product code SEZ, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEZ

Recent clearances under product code SEZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.