2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)

2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) is an FDA 510(k)-cleared medical device (K972592) 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 September 14, 1997. Regulation: 8.