AV Cardiac CT

AV Cardiac CT is a software-only medical device for advanced visualization, post-processing, and analysis of cardiac CT datasets. It includes two applications: CT Coronary Analysis (for analyzing coronary artery anatomy in patients with suspected or diagnosed coronary artery disease) and CT Functional Analysis (for analyzing heart anatomy and function). The device provides measurement and visualization tools to support physician review; it does not perform automated diagnosis or treatment recommendations.

The subject device includes new AI-based algorithms for coronary centerline extraction (CNN with deep learning), updated vessel labeling (model-based), and new lumen segmentation (KNN model), compared to the predicate's legacy non-AI algorithms. Both support DICOM input, automated segmentation with user review and editing, and CAD-RADS 2.0 stenosis categorization. The subject device adds a planning workflow module to organize visualization and measurement tools for pre-procedural review.

Not stated in this summary.

AV Cardiac CT is substantially equivalent to Philips Medical Systems' Spectral CT Applications (K150665) because both devices have the same intended use, similar indications for use, identical regulatory classification (Class II), and identical intended body part (cardiovascular anatomy). The technological differences—newer AI-based algorithms and the planning workflow—raise no new issues of safety or effectiveness, as demonstrated by performance testing data showing the algorithms meet acceptance criteria across multiple patient subgroups and clinical characteristics.