Salix

Primary DI

09369998252183

Brand

Salix

Company

ARTRYA USA INC.

Model

Salix Coronary Plaque V1.X

Device description

Salix Coronary Plaque is a web-based, non-invasive software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format. This software provides cardiologists and radiologists with interactive tools that can be used for viewing and analyzing cardiac computed tomography (CT) data for quantification and characterization of coronary plaques (i.e. atherosclerosis), stenosis and to perform calcium scoring in non-contrast cardiac CT. Salix Coronary Plaque is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional’s comprehensive diagnostic decision-making process. The software’s semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images. Users should be aware that certain views make use of interpolated data. These data are created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Published

2026-02-17

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

false

Sterile

false

Single use

true