# K243038: Salix Central

- Pathway: 510(k) (Traditional)
- Applicant: Artrya Limited
- Decided: Mar 27, 2025 after 181 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
Longest line of descent: 8 generations back to K945512 (1995). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213998: cvi42 Auto Imaging Software Application, Circle Cardiovascular Imaging, Inc. (2022) Summary page 5.

## Most influential descendants
- K251837: Salix Coronary Plaque (V1.0.0) (2025), 0 descendants of its own

## Indications for use
Salix Central is a web-based 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 tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT. Salix Central 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 cardiac CT images.

Source page: https://510kreport.com/device/K243038
Methodology: https://510kreport.com/methodology