Medical Device Manufacturer · US , Melbourne , FL

Image-Guided Neurologics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1999

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Image-Guided Neurologics, Inc. Neurology ✕

20 devices

1-12 of 20

Cleared Apr 21, 2005

NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000

Neurology · 27d

Cleared Feb 07, 2005

NAVIGUS NEXDRIVE, MODEL MI-3000

Neurology · 90d

Cleared Oct 04, 2004

NAVIGUS PASSIVE PROBE, MODEL NP-1000

Neurology · 236d

Cleared Jun 03, 2004

NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000

Neurology · 64d

Cleared Mar 02, 2004

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

Neurology · 105d

Cleared Aug 21, 2003

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

Neurology · 64d

Cleared Mar 12, 2003

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

Neurology · 82d

Cleared Feb 25, 2003

NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES

Neurology · 90d

Cleared Sep 25, 2002

NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 &...

Neurology · 89d

Cleared Oct 22, 2001

Neurology · 69d

Cleared Oct 01, 2001

NAVIGUS II TRAJECTORY GUIDE

Neurology · 67d

Cleared Aug 03, 2001

NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

Neurology · 39d