Radiological Software Device To Predict Future Breast Cancer Risk
SEZ · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.8500
Classification
FDA Product Code
SEZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.8500
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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 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.