VITREA 2, VERSION 2.1

VITREA 2, VERSION 2.1 is an FDA 510(k)-cleared medical device (K002519) 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 October 18, 2000. Regulation: 8.