MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION

MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION is an FDA 510(k)-cleared medical device (K911642) 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 May 29, 1991. Regulation: 8.