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Image-Guided Neurologics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050772NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000April 21, 2005
K043091NAVIGUS NEXDRIVE, MODEL MI-3000February 7, 2005
K040334NAVIGUS PASSIVE PROBE, MODEL NP-1000October 4, 2004
K040834NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000June 3, 2004
K033619NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000March 2, 2004
K031885NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXXAugust 21, 2003
K024201NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000March 12, 2003
K023949NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULESFebruary 25, 2003
K022100NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010September 25, 2002
K012719NAVIGUS II MROctober 22, 2001
K012366NAVIGUS II TRAJECTORY GUIDEOctober 1, 2001
K011971NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000August 3, 2001
K001097ACTIVE ARRAY CATHETER, MODEL CS-2000January 18, 2001
K001096BURR HOLE COVER, MODEL XXOctober 25, 2000
K002330NAVIGUS PEEL AWAY INTRODUCEROctober 18, 2000
K001192SELF ADHERING NAVIGUS GUIDEJune 7, 2000
K000195CRANIAL DRILLApril 20, 2000
K993682MRI EQUIPMENT COVERJanuary 20, 2000
K992796ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000October 25, 1999
K992304NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXXAugust 27, 1999