GYREX 2T-PRESTIGE

GYREX 2T-PRESTIGE is an FDA 510(k)-cleared medical device (K970005) 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 March 27, 1997. Regulation: 8.