NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 is an FDA 510(k)-cleared medical device (K033619) manufactured by Image-Guided Neurologics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2004. Regulation: 8.