HRH-63 HEAD ARRAY COIL

HRH-63 HEAD ARRAY COIL is an FDA 510(k)-cleared medical device (K002774) manufactured by Mri Devices Corp.. 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, 2000. Regulation: 8.