# K260980: cmAngio® V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Curemetrix, Inc.
- Decided: Jul 30, 2026 after 127 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
cmAngio, a proprietary artificial intelligence (Al)-based software is intended to process Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms to aid qualified interpreting physicians in the identification, visualization, and contextualization of Breast Arterial Calcifications (BAC), an incidental finding. The software functionalities include: * Detection of BAC at both the study and breast level, * Localization of BAC segments by marking detected regions on image thumbnails, * Measurement of Study-level BAC Length and View-level BAC Length, representing the extent of detected BAC findings. * Normalization of BAC length and comparison against an age-matched Reference Library to report and display an Age-based BAC Percentile, and * Reporting of Age-based BAC Prevalence based on the same Reference Library. The software is intended to be used by qualified interpreting physicians in parallel with breast cancer screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.

Source page: https://510kreport.com/device/K260980
Methodology: https://510kreport.com/methodology