510(k) DEN240047
DEN240047 is an FDA 510(k) premarket notification submitted by Clairity, Inc. for the device "Allix5". The FDA issued a decision of De Novo Granted on May 30, 2025. The device falls under product code SEZ (Radiological Software Device To Predict Future Breast Cancer Risk), a Class II device regulated under 21 CFR 892.8500.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 30, 2025
- Date Received
- September 6, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Software Device To Predict Future Breast Cancer Risk
- Device Class
- Class II
- Regulation Number
- 892.8500
- Review Panel
- RA
- Submission Type
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.