VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)

VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) is an FDA 510(k)-cleared medical device (K141302) 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 July 31, 2014. Regulation: 8.