
Hitachi Medical Systems America, Inc.
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AIRIS ELITE RAPID BODY COIL is an FDA 510(k)-cleared medical device (K050307) 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 February 27, 2005. Regulation: 8.