Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is an FDA 510(k)-cleared medical device (K260324) manufactured by Canon Medical Informatics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2026. Regulation: 8.