SIGNA BREAST COIL AND ARRAY ACCESSORY

SIGNA BREAST COIL AND ARRAY ACCESSORY is an FDA 510(k)-cleared medical device (K923025) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 1992. Regulation: 8.