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FDA-cleared K250754

cmAngio® (V1.6)

CureMetrix, Inc.

Authorized purpose: cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence or absence of breast arterial calcifications at the study and breast level in full-field digital mammography and digital breast tomosynthesis screening mammograms and marks BAC segments on image thumbnails for localization.

Modality
Mammography/DBT
Anatomy
Female breasts; breast arterial calcification
Decision
2025-04-10
FDA-cleared K232367

cmAngio® V1.0

CureMetrix, Inc.

Authorized purpose: cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified interpreting-physician review; it is not primary breast-cancer interpretation or a standalone diagnostic or treatment decision tool.

Modality
Mammography/DBT
Anatomy
Breast; breast arterial calcifications
Decision
2023-10-05
FDA-cleared K183285

cmTriage

CureMetrix, Inc

Authorized purpose: Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-03-08