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FDA-cleared K251837

Salix Coronary Plaque (V1.0.0)

Artrya Limited

Authorized purpose: Salix Coronary Plaque (V1.0.0) is a web-based adjunctive tool for qualified cardiologists and radiologists to quantify and characterize coronary plaque and stenosis and perform calcium scoring from adult cardiac CT DICOM images.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-08-20
FDA-cleared K243038

Salix Central

Artrya Limited

Authorized purpose: Salix Central is a web-based adjunctive tool for qualified professionals to view, post-process, and analyze cardiac CT DICOM images for physician-identified coronary plaque and stenosis assessment and non-contrast calcium scoring.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2025-03-27