Salix
ARTRYA USA INC. · Model Salix Coronary Plaque V1.X · UDI-DI 09369998252183
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE |
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