# DEN240047: Allix5

- Pathway: De Novo (Direct)
- Applicant: Clairity, Inc.
- Decided: May 30, 2025 after 266 days
- Product code: SEZ (Radiological Software Device To Predict Future Breast Cancer Risk)
- Device class: 2
- Regulation: 21 CFR 892.8500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Clairity Allix5 software device is intended to generate a 5-year risk prediction of breast cancer based on a bilateral screening mammogram. Allix5 provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics. Eligible patients do not have a known breast cancer at presentation for their screening mammogram. Allix5 is not intended to diagnose or detect breast cancer, or to provide care recommendations. Allix5 is not intended to replace or to be used as the sole determinant for clinical decision-making. Allix5 output is intended to be considered after the radiologist has completed the interpretation of the screening mammogram. Allix5 analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia and Selenia Dimensions Mammography Systems; it does not analyze synthetic-2D images.

Source page: https://510kreport.com/device/DEN240047
Methodology: https://510kreport.com/methodology