K-number	K250754
Device name	cmAngio® (V1.6)
Applicant	Curemetrix, Inc.
Product code	QIH
Device class	Class II
Decision date	Apr 10, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

cmAngio (V1.6) is an AI-based software that processes screening mammograms to detect and identify Breast Arterial Calcification (BAC) as an incidental finding. It works with both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) images, marking BAC segments on image thumbnails for physician localization. The software is used by qualified interpreting physicians in parallel with routine breast screening workflow and is not intended for primary breast cancer detection.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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cmAngio® (V1.6)

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