VITREA2 VERSION 3.8.1

VITREA2 VERSION 3.8.1 is an FDA 510(k)-cleared medical device (K060378) 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 March 8, 2006. Regulation: 8.