1 device · 1 company · 2025
Product code SEZ: Radiological Software Device To Predict Future Breast Cancer Risk
1 device under product code SEZ, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Radiological Software Device To Predict Future Breast Cancer Risk. 21 CFR 892.8500, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Allix5DEN240047 · De Novo | Clairity, Inc. | Radiology | database entry |
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