Vendor source
Reviewed 11 May 2026
Completeness Comprehensive (81%)
ClariSIGMAM
ClariPi Inc.The ClariSIGMAM is a breast density assessment solution that provides density estimates from standard digital mammograms. It automatically analyzes 2D digital mammograms to calculate breast tissue composition. It assesses breast density and generates a breast density grade in line with the American College of Radiology's BI-RADS density classification scales. The breast density output by ClariSIGMAM is designed to display on mammography workstations or PACS as a DICOM mammography structured report or secondary capture.
Supported by 2 papers
General Information
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Main task
Not specified
Subspeciality
Disease targeted
Regulatory Information
Pathway:
MDD
Class:
Class I
Verified by Health AI Register
Pathway:
510(k) cleared
Class:
Class II
Verified by Health AI Register
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
A novel deep learning-based approach to high accuracy breast density estimation in digital mammography
SPIE Proceedings · Mar 2017
Reliability of Computer-Assisted Breast Density Estimation: Comparison of Interactive Thresholding, Semiautomated, and Fully Automated Methods
American Journal of Roentgenology · May 2016
Technical Specifications
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AI Platforms
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Source: Vendor | First published: Oct 4, 2023 | Last updated: May 11, 2026