TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM is an FDA 510(k)-cleared medical device (K103182) manufactured by Genoray Co., Ltd.. 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 13, 2011. Regulation: 8.