HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION

HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION is an FDA 510(k)-cleared medical device (K934485) 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 January 24, 1994. Regulation: 8.