SEZ — Radiological Software Device To Predict Future Breast Cancer Risk Class II
FDA product code SEZ covers "Radiological Software Device To Predict Future Breast Cancer Risk", a Class II medical device regulated under 21 CFR 892.8500. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEZ
- Device Class
- Class II
- Regulation Number
- 892.8500
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240047 | clairity | Allix5 | May 30, 2025 |