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SEZClass II

Radiological Software Device To Predict Future Breast Cancer Risk

21 CFR 892.8500 / Radiology
FDA source (opens on fda.gov)

SEZ is the FDA product code for Radiological Software Device To Predict Future Breast Cancer Risk, a class II device type, regulated under 21 CFR 892.8500. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SEZ
Device name
Radiological Software Device To Predict Future Breast Cancer Risk
FDA 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.
Regulation
21 CFR 892.8500
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SEZ

By decision year
1 clearance under product code SEZ with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SEZ by decision year
YearClearances
20251

Applicants with the most clearances

Product code SEZ
Applicants holding the most 510(k) clearances under product code SEZ
ApplicantClearances
Clairity, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code