Radiological Software Device To Predict Future Breast Cancer Risk
Radiology · 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 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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code