GE SHOULDER SURFACE COIL, CAT. #M1085AN

GE SHOULDER SURFACE COIL, CAT. #M1085AN is an FDA 510(k)-cleared medical device (K892235) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 1989. Regulation: 8.