MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)

MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) is an FDA 510(k)-cleared medical device (K971016) 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 June 5, 1997. Regulation: 8.