INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 is an FDA 510(k)-cleared medical device (K003510) manufactured by Visualization Technology, 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 February 11, 2001. Regulation: 8.