ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3

ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 is an FDA 510(k)-cleared medical device (K990442) 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 May 10, 1999. Regulation: 8.