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Xitec Holdings, LLC
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XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K033066) manufactured by Xitec Holdings, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2003. Regulation: 8.