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Radionics, A Division of Tyco Healthcare Group LP
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XPLAN 2.2 WITH THE BODY SYSTEM is an FDA 510(k)-cleared medical device (K013661) manufactured by Radionics, A Division of Tyco Healthcare Group LP. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 2001. Regulation: 8.