Vitrea, Version 7.0 Medical Image Processing Software

Vitrea, Version 7.0 Medical Image Processing Software is an FDA 510(k)-cleared medical device (K150258) 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 4, 2015. Regulation: 8.