Vitrea CT Myocardial Perfusion

Vitrea CT Myocardial Perfusion is an FDA 510(k)-cleared medical device (K150104) manufactured by Vital Images, 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 April 16, 2015. Regulation: 8.