MARK 5000 PHASED ARRAY SHOULDER COIL

MARK 5000 PHASED ARRAY SHOULDER COIL is an FDA 510(k)-cleared medical device (K983143) manufactured by Usa Instruments, 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 November 15, 1998. Regulation: 8.