Company · US

Image-Guided Neurologics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2005. Name variants (Inc, Corp, punctuation) are merged.

22510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
HAW	Neurological Stereotaxic Instrument	15
GWG	Endoscope, Neurological	1
GXR	Cover, Burr Hole	1
HBB	Motor, Drill, Pneumatic	1
HBL	Holder, Head, Neurosurgical (Skull Clamp)	1
HCA	Catheter, Ventricular	1
LNH	System, Nuclear Magnetic Resonance Imaging	1
MOS	Coil, Magnetic Resonance, Specialty	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Apr 21, 2005	K050772	NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 Image-Guided Neurologics, Inc.	HAW
Feb 7, 2005	K043091	NAVIGUS NEXDRIVE, MODEL MI-3000 Image-Guided Neurologics, Inc.	HAW
Oct 4, 2004	K040334	NAVIGUS PASSIVE PROBE, MODEL NP-1000 Image-Guided Neurologics, Inc.	HAW
Jun 3, 2004	K040834	NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 Image-Guided Neurologics, Inc.	HAW
Mar 2, 2004	K033619	NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 Image-Guided Neurologics, Inc.	HAW
Aug 21, 2003	K031885	NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX Image-Guided Neurologics, Inc.	HBL
Mar 12, 2003	K024201	NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 Image-Guided Neurologics, Inc.	HAW
Feb 25, 2003	K023949	NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES Image-Guided Neurologics, Inc.	HAW
Sep 25, 2002	K022100	NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 Image-Guided Neurologics, Inc.	HAW
Oct 22, 2001	K012719	NAVIGUS II MR Image-Guided Neurologics, Inc.	HAW
Oct 1, 2001	K012366	NAVIGUS II TRAJECTORY GUIDE Image-Guided Neurologics, Inc.	HAW
Aug 3, 2001	K011971	NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 Image-Guided Neurologics, Inc.	HAW
Jan 18, 2001	K001097	ACTIVE ARRAY CATHETER, MODEL CS-2000 Image-Guided Neurologics, Inc.	MOS
Oct 25, 2000	K001096	BURR HOLE COVER, MODEL XX Image-Guided Neurologics, Inc.	GXR
Oct 18, 2000	K002330	NAVIGUS PEEL AWAY INTRODUCER Image-Guided Neurologics, Inc.	GWG
Jun 7, 2000	K001192	SELF ADHERING NAVIGUS GUIDE Image-Guided Neurologics, Inc.	HAW
Apr 20, 2000	K000195	CRANIAL DRILL Image-Guided Neurologics, Inc.	HBB
Jan 20, 2000	K993682	MRI EQUIPMENT COVER Image-Guided Neurologics, Inc.	LNH
Oct 25, 1999	K992796	ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 Image-Guided Neurologics, Inc.	HCA
Aug 27, 1999	K992304	NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX Image-Guided Neurologics, Inc.	HAW
Aug 12, 1999	K990907	REMOTE INTRODUCER, MODEL PI-1000 Image-Guided Neurologics, Inc.	HAW
Feb 12, 1999	K983539	TRAJECTORY GUIDE, MODEL # TGX-XXX Image-Guided Neurologics, Inc.	HAW

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

Get alerts for these product codes