AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE

AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE is an FDA 510(k)-cleared medical device (K032232) 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 September 28, 2003. Regulation: 8.