SEZ · Class II · 21 CFR 892.8500

FDA Product Code SEZ: Radiological Software Device To Predict Future Breast Cancer Risk

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.

Leading manufacturers include Clairity, Inc..

1
Total
0
Cleared
266d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Radiological Software Device To Predict Future Breast Cancer Risk Devices (Product Code SEZ)

1 devices
1–1 of 1
Not Cleared May 30, 2025
Allix5
DEN240047
Clairity, Inc.
Radiology · 266d

About Product Code SEZ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SEZ since 2025, with 0 receiving FDA clearance (average review time: 266 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SEZ devices are reviewed by the Radiology panel. Browse all Radiology devices →