Salix Central

Salix Central is a web-based software application for viewing, post-processing, and analyzing cardiac CT images. It provides tools for qualitative and quantitative assessment of coronary plaques and stenosis in coronary CT angiography, and performs calcium scoring in non-contrast cardiac CT. The software is designed as an adjunctive tool for qualified medical professionals and is not intended to replace a physician's comprehensive diagnostic decision-making.

Salix Central uses machine learning-enabled algorithms for semi-automatic centerline extraction, vessel wall segmentation, and calcium scoring. It is delivered as a SaaS model hosted on AWS cloud services via Google Chrome client-server application. Like the predicate, it supports DICOM 3.0 or higher, provides 2D/3D imaging, multiplanar reformats, and measurement tools including distance, diameter, area, and Hounsfield units. Both devices are Class II and intended for cardiac CT analysis by qualified professionals.

FDA 21 CFR Part 820.30 design controls; IMDRF/SaMD WG/N12FINAL:2014; ISO 13485:2016; IEC 62304:2015; ISO 14971:2019; and NEMA 3.1-3.20 (2016) DICOM standards. Verification and validation testing followed FDA Guidance documents on premarket submissions for software-contained medical devices and cybersecurity management.

Salix Central and the predicate cvi42 Auto Imaging Software Application share identical indications for use, target similar qualified end-users, provide overlapping measurement and visualization capabilities, and operate on equivalent platforms for cardiac image analysis. The ML-enabled semi-automatic features in Salix Central represent a refinement of the same functional intent (coronary assessment and calcium scoring) performed by the predicate's semi-automatic workflows. Comprehensive performance validation on 363 independent cardiac CT studies across multiple manufacturers showed Salix Central exceeded all pre-defined acceptance criteria, demonstrating functional parity with the predicate's intended clinical purpose.