MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL

MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL is an FDA 510(k)-cleared medical device (K923140) manufactured by Hitachi Medical Systems America, 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 December 23, 1992. Regulation: 8.