SEZ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Radiological Software Device To Predict Future Breast Cancer Risk

Device class

Class II (moderate risk)

Regulation

21 CFR 892.8500

Medical specialty

Radiology

FDA 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.

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