GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0

GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 is an FDA 510(k)-cleared medical device (K925985) manufactured by Elscint, 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 6, 1993. Regulation: 8.