VITREA 2 CT PERFUSION OPTION

VITREA 2 CT PERFUSION OPTION is an FDA 510(k)-cleared medical device (K003639) 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 January 22, 2001. Regulation: 8.