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510(k) Data Aggregation
K Number
K243038Device Name
Salix Central
Manufacturer
Date Cleared
2025-03-27
(181 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Artrya Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 and evaluating cardiac CT images.
Device Description
Salix Central is a web-based software application, hosted on AWS cloud services, delivered using a SaaS model. The software provides interactive, post-processing tools for trained radiologists or cardiologists for viewing, and characterizing cardiac computed tomography (CT) image data obtained from a CT scanner. The physician-driven coronary analysis is used to review CT image data to prepare a standard coronary report that may include the presence and extent of physician-identified coronary plaques (i.e., atherosclerosis) and stenosis, and assessment of calcified plaque (calcium scoring). The Cardiac CT image data are physician-ordered and typically obtained from patients who underwent CCTA or CAC CT for evaluation of CAD or suspected CAD.
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