XISCAN 6000 IMAGING SYSTEM

XISCAN 6000 IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K003568) manufactured by Xitec, 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 December 26, 2000. Regulation: 8.