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FDA-authorized DEN240047

Allix5

Clairity, Inc.

Authorized purpose: Allix5 generates a five-year breast-cancer-risk prediction from bilateral screening mammograms for eligible patients without known breast cancer at presentation; it is not intended to diagnose or detect cancer, recommend care, or serve as the sole determinant of care.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-05-30