Neurological Stereotaxic Instrument
FDA product code HAW · 410 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.4560
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-04-05 – 2026-09-10
HAW
2000-01-11
HAW
1999-12-29
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
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HAW
1999-12-21
SNN FLUORO NAVIGATION SYSTEM
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HAW
1999-12-07
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
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HAW
1999-11-22
3D1 MICROPOSITIONING HEADSTAGE
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HAW
1999-11-03
AXON MP-1 MICROPOSITIONER
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HAW
1999-11-02
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
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HAW
1999-10-08
VIEWPOINT ENT/ORTHOPEDIC OPTION
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HAW
1999-09-24
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
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HAW
1999-09-17
@ TARGET
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HAW
1999-09-10
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
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HAW
1999-08-27
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
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HAW
1999-08-27
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
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HAW
1999-08-12
REMOTE INTRODUCER, MODEL PI-1000
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HAW
1999-07-20
ELEKTA STEREOTACTIC GUIDE
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HAW
1999-07-12
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
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HAW
1999-07-08
VIEWPOINT TOOLS- STERRAD
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HAW
1999-06-25
FRAMELESS NEUROMATE
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HAW
1999-06-23
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
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HAW
1999-05-19
VECTORVISION2
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HAW
1999-04-29
OPTICAL TRACKING SYSTEM (OTS)
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HAW
1999-04-22
FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
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HAW
1999-03-30
VIEWPOINT PASSIVE TOOL OPTION
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HAW
1999-03-30
VIEWPOINT MICROSCOPE OPTION
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HAW
1999-03-04
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
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HAW
1999-02-12
TRAJECTORY GUIDE, MODEL # TGX-XXX
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HAW
1999-01-28
PHILIPS EASYGUIDE
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HAW
1999-01-14
STEALTHSTATION SYSTEM
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HAW
1999-01-13
SNN SCOUT
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HAW
1998-12-18
NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
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HAW
1998-12-04
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
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HAW
1998-11-23
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
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HAW
1998-11-18
OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
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HAW
1998-11-10
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
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HAW
1998-10-29
VECTORVISION SPINE MODULE
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HAW
1998-10-13
PHILIPS EASYGUIDE
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HAW
1998-09-23
MAYFIELD ACCISS OPTICAL SYSTEM
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HAW
1998-08-24
MAGELLAN
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HAW
1998-08-14
CAROLINE GUIDE
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HAW
1998-08-07
STEALTHSTATION SYSTEM DIGITIZER CHANGE
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HAW
1998-08-06
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
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HAW
1998-08-05
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
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HAW
1998-07-09
NAVITRACK
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HAW
1998-07-01
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
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HAW
1998-05-18
ATLASPLAN
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HAW
1998-04-21
OPTICAL TRACKING SYSTEM (OTS)
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HAW
1998-03-31
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
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HAW
1998-03-02
LEKSELL STEREOTACTIC SYSTEM
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HAW
1998-01-21
STEALTHSTATION SYSTEM
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HAW
1997-11-21
STEALTHSTATION SYSTEM
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HAW
1997-11-17
CAROLINE GUIDE/DELIA LOCALIZER
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HAW
1997-09-16
STEALTHSTATION PASSIVE INSTRUMENT OPTION
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HAW
1997-08-19
REGULUS NAVIGATOR
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HAW
1997-07-14
SNT STEREOTACTIC LOCALIZATION SYSTEM
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HAW
1997-06-16
SNT DISPOSABLE BIOPSY NEEDLE
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HAW
1997-06-04
ISG FAMILY OF VIEWING WANDS
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HAW
1997-06-02
OPTICAL TRACKING SYSTEM (OTS)
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HAW
1997-05-22
VECTORVISION
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HAW
1997-05-19
VIEWPOINT - 3.0 SOFTWARE
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HAW
1997-05-09
NEUROMATE STEREOTACTIC SYSTEM
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HAW
1997-04-23
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
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HAW
1997-01-10
OPTICAL DIGITIZER OPTION FOR VIEW POINT
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HAW
1996-11-08
PHILIPS EASYGUIDE NEURO
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HAW
1996-10-25
STEALTHSTATION SYSTEM
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HAW
1996-10-23
OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
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HAW
1996-08-12
BRAINLAB HEADPINS
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HAW
1996-08-07
COSGROVE DEPTH ELECTRODE KIT(CDEK)
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HAW
1996-07-26
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
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HAW
1996-05-29
ISG VIEWING WAND
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HAW
1996-05-10
MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
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HAW
1996-04-30
MAYFIELD-ACCISS WORKSTATION
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HAW
1996-02-29
CODMAN FIDUCIAL MARKER SYSTEM
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HAW
1996-02-02
BRAINLAB STEROTATIC HEADRING
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HAW
1996-01-24
STEALTHSTATION
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HAW
1995-10-26
CRW-1 SYSTEM
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HAW
1995-10-13
REGULUS MEASUREMENT UNIT
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HAW
1995-09-01
LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
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HAW
1995-03-14
STEREOPLAN
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HAW
1995-01-20
LEKSELL SURGIPLAN
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HAW
1994-03-22
NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
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HAW
1993-08-20
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
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HAW
1992-11-23
AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
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HAW
1992-07-10
CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION
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HAW
1992-05-11
BRAINSCAN WORKSTATION
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HAW
1991-03-07
STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
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HAW
1990-07-03
GNOMOS STEREOTACTIC DEVICE
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HAW
1990-05-31
COOK STEREOTAXIC GUIDE
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HAW
1989-11-07
WESTCO MADAYAG PAB NEEDLE
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HAW
1989-09-01
CASS SYSTEM
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HAW
1988-08-09
LAITINEN'S TRIGEMINUS STEREOGUIDE
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HAW
1988-08-01
THE LAITINEN STEREOTACTIC SYSTEM
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HAW
1988-03-11
OBT STEREOTACTIC SYSTEM
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HAW
1988-03-03
ARC ADAPTER ASSEMBLY
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HAW
1988-02-12
TARGET PROGRAM & EPSON HX-20 COMPUTER
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HAW
1987-05-08
COMPASS STEREOTACTIC POSITIONING SYSTEM
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HAW
1986-08-12
KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
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HAW
1986-06-18
COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
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HAW
1986-02-20
GHAJAR INTRAVENTRICULAR CATHETER GUIDE
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HAW
1985-08-21
GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY
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HAW
1985-07-30
KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
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