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Device radiological software device to predict future breast cancer risk
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.
Product CodeSEZ
Regulation Number 892.8500
Device Class 2


Premarket Reviews
ManufacturerDecision
CLAIRITY, INC.
  GRANTED 1

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