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Ge Medical Systems, Inc.
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HISPEED X/I SMART GANTRY OPTION is an FDA 510(k)-cleared medical device (K012385) manufactured by Ge Medical Systems, 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 August 9, 2001. Regulation: 8.