AVIEW CAC

AVIEW CAC is a software tool that analyzes chest CT scans to measure calcified plaques in coronary arteries and calculate the Agatston score. It segments the right and left coronary arteries, provides risk stratification based on calcium score, gender, and age, and is designed for radiologists and cardiologists. The software supports storing, transferring, and displaying CT image data sets on personal computers and mobile devices.

AVIEW CAC version 2.0 maintains the same materials, energy source, and control mechanisms as the predicate device. Software modifications include UI changes to the login, worklist, and CAC pages; addition of a summary page; a new arterial age calculation function based on Agatston score; and updated system requirements. The core intended use, indications, and algorithms remain unchanged from the predicate.

Not stated in this summary.

The device is substantially equivalent because it performs the identical clinical function as the predicate device (quantitative coronary artery calcium analysis using the same Agatston score methodology) without introducing new scientific principles or safety risks. Although UI and display features differ, these changes are characterized as non-significant and do not affect the fundamental algorithm or diagnostic capability. Non-clinical verification and validation testing confirmed performance equivalence to the predicate.