A BREAST COIL FOR THE GYREX 2T-DIX

A BREAST COIL FOR THE GYREX 2T-DIX is an FDA 510(k)-cleared medical device (K923897) 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 20, 1992. Regulation: 8.