Canon Medical Informatics, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K260324

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

Canon Medical Informatics, Inc.

Authorized purpose: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.

Modality: CT/CTA
Anatomy: Aortic valve/root, LVOT and ventricles, coronary ostia, cardiac structures, and iliac/femoral/abdominal aortic access vessels
Decision: 2026-05-22

Cardiac imaging

FDA-cleared K252217

CT VScore+

Canon Medical Informatics, Inc.

Authorized purpose: CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and highlighted calcium segmentation for qualified clinical review.

Modality: CT/CTA
Anatomy: Heart/Cardiovascular
Decision: 2025-11-28

Cardiac imaging Quantification and segmentation