GYREX 2T-DLX

GYREX 2T-DLX is an FDA 510(k)-cleared medical device (K915601) 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 February 13, 1992. Regulation: 8.