MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE

MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE is an FDA 510(k)-cleared medical device (K984274) 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, 1999. Regulation: 8.