CAC

Primary DI

19356870000045

Brand

CAC

Company

4DMEDICAL LIMITED

Model

3.1.x

Device description

CAC Software is intended for use as a noninvasive postprocessing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. CAC Software uses machine learning to analyze non contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. CAC Software is limited to the quantification of detected possible calcifications in adult patients over 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The CAC Software results are not intended to be used on a standalone basis for clinical decision making or otherwise preclude clinical assessment of CT images.

Published

2026-10-13

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

false