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Image-Guided Neurologics, Inc.
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NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 is an FDA 510(k)-cleared medical device (K024201) 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 11, 2003. Regulation: 8.