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Salix

ARTRYA USA INC. · Model Salix Central V1.X · UDI-DI 09369900000857

QIH Prescription

510(k) clearances

Adverse events

Recalls

236

Facilities

Description

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. Salix Central is a prescription use only device.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.