510(k) K033619

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 by Image-Guided Neurologics, Inc. — Product Code HAW

K033619 is an FDA 510(k) premarket notification submitted by Image-Guided Neurologics, Inc. for the device "NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000". The FDA issued a decision of Substantially Equivalent on March 2, 2004. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Image-Guided Neurologics, Inc. has at least 10 other 510(k) clearances on record.