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Hitachi Medical Systems America, Inc.
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GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM is an FDA 510(k)-cleared medical device (K113341) 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 2, 2012. Regulation: 8.