Product Code: HAW FDA class 2 21 CFR 882.4560

Neurological Stereotaxic Instrument

Neurology

The Neurological Stereotaxic Instrument is a frame-based or frameless guidance device used in neurosurgery to precisely target specific intracranial coordinates for biopsy, electrode placement, ablation, or other procedures using a three-dimensional coordinate system referenced to external landmarks. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAW under regulation 21 CFR 882.4560 in the Neurology specialty. No third-party review flag applies.

510(k)s
418
FEI Numbers
246
Registration Numbers
246
Unique Applicants
166
Years Active
46

Basic Information

Product Code
HAW
Device Class
FDA class 2
Regulation Number
882.4560
Medical Specialty
Neurology
Review Panel
NE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 418 510(k) clearances via K numbers.

K Number Device Name
K250505 EZ-FIDUCIALS
K242575 Stereotaxic Guiding Surgical Devices, NaoTrac S
K241327 Navient Image Guide Navigation System (955-NC-NC), Cranial
K243698 Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
K243657 ClearPoint System (Software Version 3.0)
K241333 Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K242480 FLASH EVD System (10-0002)
K242351 Zeta Cranial Navigation System (ZNS131-US)
K233703 Bone Anchor (NGS-BA-01)
K233155 ClearPointer Optical Navigation Wand
K233144 ClearPoint Bone Screw Fiducials
K233141 SmartFrame OR
K233903 Zeta Cranial Navigation System (ZNS131-US)
K233243 ClearPoint System (Software Version 2.2)
K231976 StealthStation Cranial Software, v3.1.5 (9735585)
K232102 ClearPoint Array System (Version 1.2)
K223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
K230661 Zeta Cranial Navigation System
K223288 Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
K231103 ROSA ONE Brain Application
K231392 NaviNetics Reusable Stereotactic System (NN1000)
K220072 Sinobot X1
K223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
K223577 Localite TMS Navigator TS
K221544 MagVenture TMS Atlas Neuro Navigation System
K230201 Disposable Pre-calibrated Brain Biopsy Needle 2.0
K212194 Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
K222519 ClearPoint System
K213989 Cranial EM System
K220897 Disposable Brain Biopsy Needle 2.0
K221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K214065 ROSA ONE Brain application
K214040 ClearPoint Array System (version 1.1)
K210109 visor2 system
K212397 StealthStation S8 Cranial v2.0
K201435 Molecular Flow Simulations
K210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
K211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
K203251 SOLOPASS System
K210700 NaviNetics D1 Stereotactic System
K201752 Disposable Pre-calibrated Suction
K202575 ClearPoint Array System
K203639 StealthStation Cranial Software v1.3.2
K192703 Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
K201175 StealthStation Cranial Software v1.3.0
K200511 ROSA ONE Brain application
K191422 Neural Navigator
K200079 ClearPoint System and Accessories
K192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
K191597 Stealth Autoguide System, Midas Rex Legend Depth Stop System
K190250 Microscope Navigation
K183276 7D Surgical System
K190887 Leksell Vantage Stereotactic System
K190672 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
K183325 Modus Nav
K191400 Voyager Trajectory Array Guide (V-TAG)
K182417 ROSA ONE Brain Application
K182000 AQrate Robotic Assistance System
K181041 7D Surgical System Cranial Application
K181706 neuromate Gen III
K180854 Voyager Trajectory Array Guide (V-TAG)
K180206 neuromate Gen III
K172444 ROSA BRAIN (v3.0.0.5)
K172820 Microscope Navigation Software
K171123 Leksell Vantage Stereotactic System
K163666 neuro inspire
K163209 Fiagon Navigation System
K163439 NaviENT
K162655 StealthConnect Remote Viewing, Planning and Collaboration System
K162309 StealthStation S8 System Platforms and StealthStation Cranial Software
K162929 Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
K162604 Cranial Reducing Tubes
K160811 CRW STEREOTACTIC SYSTEM
K153660 StealthStation System with Cranial Software
K152764 EXACTECH GPS
K160523 BrightMatter Guide with BrightMatter Pointer
K151156 Fiagon Navigation System
K153281 BrightMatter Guide with Surface Trace Registration
K160434 ClearPoint System
K152558 Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K151359 ROSA Brain
K143420 SYMBIS Surgical System
K142505 ClearPoint System
K150301 NavSuite3 Kit
K150216 Synergy Cranial
K143241 MDT Navigable Brain Biopsy Cannula
K142024 BRIGHTMATTER NAVIGATION SYSTEM
K141833 STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K142344 DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
K141559 V-GUIDE FOR VENTRICULOSTOMIES
K140705 NAVIGABLE BRAIN BIOPSY CANNULA SET
K133444 STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K140868 STRYKER KWIC NEEDLE
K132755 NEUROMATE FRAMELESS GEN II
K132611 MICROTABLE SYSTEM
K131214 CRANIAL MAP NEURO
K130874 STRYKER NAV3I PLATFORM
K130608 QUADCUT
K122211 SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
K122096 KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K121950 MICROTARGETING XL STAR DRIVE SYSTEM
K120812 RENAISSANCE
K110644 PRAEZIS PLUS
K112094 BRAIN BIOPSY NEEDLE
K111558 SURGICASE GUIDE
K112469 GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
K113228 RENAISSANCE SYSTEM
K101627 IPLAN
K110911 RENAISSANCE SYSTEM
K103192 NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
K101791 ROSA SURGICAL DEVICE
K102130 TENZING SYSTEM
K100038 DISPOSABLE REFLECTIVE MARKER SPHERES
K092467 VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
K100314 IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K092192 WAYPOINT STEREOTACTIC SYSTEM
K092239 ROSA SURGICAL DEVICE, MODEL ROSA 1.1
K090190 WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
K083597 SONOWAND INVITE
K092562 MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
K090240 MONTERIS MEDICAL UFO
K082060 CRANIAL IMAGE GUIDED SURGERY SYSTEM
K080355 LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K083565 PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K081867 MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K082267 PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K073615 BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
K081232 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
K080875 PIGALILEO 4TH GENERATION SYSTEM
K080450 STRYKER POWER TOOL NAVIGATOR ATTACHMENT
K080678 UNI-KNEE 2.0
K080547 ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
K073467 SPINEASSIST SYSTEM
K080250 LEKSELL SURGIPLAN, MODEL 1006947
K072899 ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
K072806 MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
K072271 STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
K072267 TOTAL HIP SURGETICS NAVIGATION SYSTEM
K072716 VECTOR VISION HIP
K072573 VECTORVISION HIP AND HIP SR
K070556 BRAINSUITE NET
K071929 NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
K063607 SPINEASSIST SYSTEM
K070731 PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
K071714 NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
K071334 DEPUY CAS HEMI ASR HIP INSTRUMENTS
K071135 DEPUY CI HIP INSTRUMENTATION
K070106 VV FLUORO 3D
K061479 ARGOS
K063408 CTLOGICS NAVIGATIONS SYSTEMS
K062358 MODIFICATION TO VECTORVISION TRAUMA
K062640 STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K063028 VECTORVISION HIP SR
K062228 ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
K061362 PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
K062086 NAVIVISION
K061224 LAPDOC I
K061248 AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K062146 UNI KNEE SURGETICS NAVIGATION SYSTEM
K060727 VECTORVISION HIP
K053348 STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K060556 BRIGIT SURGICAL DEVICE
K060808 BRAINPRO, BRAINPRO ACCESS
K053159 VECTORVISION SPINE
K060336 NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
K060282 TOTAL KNEE SURGETICS NAVIGATION SYSTEM
K053542 SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
K053164 IPLAN FLOW
K060121 BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS
K060468 VECTORVISION HIP
K052623 IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052966 CI KNEE, CI MI TKR
K053127 IPLAN
K052425 ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION
K052840 IGI-SYSTEM
K051734 GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
K052851 VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
K052213 NAVIGATION SW HIP 3.1 ON CI
K052178 DEPUY CAS HIP INSTRUMENTATION
K051676 SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
K050651 MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K051746 ELEKTA ESARTE FRAME SYSTEM
K051724 ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051029 STELTHSTATION WIRELESS SURGEON MOUSE
K031196 SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
K050438 STEALTHSTATION SYSTEM UPDATE
K041897 MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
K050897 NAVIPRO SHOULDER SOFTWARE MODULE
K050973 MODIFICATION TO: VOYAGER LINUX
K042543 IPLAN! DIGITAL TEMPLATING
K050752 AESCULAP ORTHOPILOT 2 THA V 2.0
K050772 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
K050615 STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
K042721 KOLIBRI SPINE
K050377 NBD HEAD SCREW
K043223 DEPUY CAS KNEE INSTRUMENTATION
K042513 VECTORVISION OSTEOTOMY
K043091 NAVIGUS NEXDRIVE, MODEL MI-3000
K043536 NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
K042512 VECTORVISION ACL
K043088 MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
K041477 PATHFINDER
K041703 IPLAN!
K042391 KOLIBRI IMAGE GUIDED SURGERY SYSTEM
K041899 VECTORVISION UNI-KNEE
K040334 NAVIGUS PASSIVE PROBE, MODEL NP-1000
K041330 IPLAN! FLOW
K033341 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K040368 VECTORVISION HIP 3.0
K040979 ELEKTA MICRODRIVE, MODEL 916716
K031454 ACUMEN SURGICAL NAVIGATION SYSTEM
K041369 NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
K040834 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
K033668 NAVIPRO KNEE SOFTWARE MODULE
K033619 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
K033223 ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K023651 VECTORVISION CRANIAL/ENT
K033340 LEKSELL SURGIPLAN WITH IMAGEMERGE
K033011 ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033621 NDI PASSIVE SPHERES
K033413 SPINEASSIST DEVICE
K032917 NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
K031732 EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K032054 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
K031337 ACUMEN SURGICAL NAVIGATION SYSTEM
K031770 CI TKR/UKR
K031999 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
K031980 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
K024192 VECTORVISION FLUORO3D
K022579 STRYKER NAVIGATION SYSTEM-KNEE MODULE
K030827 NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
K031156 NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
K023424 IGI-SYSTEM
K030343 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
K030764 Z-BOX
K030552 IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K024201 NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
K023949 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K030106 STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
K022364 NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
K022365 STRYKER NAVIGATION SYSTEM - HIP MODULE
K022126 CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
K023975 VOYAGER LINUX
K021798 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
K021980 HIP MODULE FOR THE STEALTHSTATION SYSTEM
K021306 VECTORVISION CT-FREE KNEE
K021815 SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K022100 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
K020631 IPLAN
K021760 NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
K022460 SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
K022414 STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
K022074 SPHERZ
K013396 ALPHA DRIVE SYSTEM
K021327 ORTHOPILOT HTO MODULE
K014256 KOLIBRI IGS SYSTEMS
K014113 ENDOMAP
K020764 NAVIPRO
K020298 GALILEO CAS/NAV TKR SYSTEM
K013569 ORTHOPILOT 2
K013428 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
K012448 VECTORVISION TRAUMA
K020338 STEALTHSTATION WITH FLUOROMERGE SOFTWARE
K012938 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
K012937 KNEE MODULE FOR THE STEALTHSTATION SYSTEM
K011255 3D LINE STEROTACTIC HARDWARE ACCESSORIES
K013861 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
K012380 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
K013257 HEMI-ARC SURGICAL NAVIGATOR
K012719 NAVIGUS II MR
K012886 CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
K013025 MODIFICATION TO FLOUROLAB PLUS
K012366 NAVIGUS II TRAJECTORY GUIDE
K010602 VECTORVISION HIP
K012564 MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
K010612 VECTORVISION KNEE
K010204 STRYKER NAVIGATION SYSTEM-KNEE MODULE
K011775 MICRO TARGETING DRIVE SYSTEM
K010968 VECTORVISION CT/FLUORO
K011992 FHC MICROTARGETING DRIVE SYSTEM
K011971 NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
K003589 VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003486 STEREOTACTIC FRAME BASED SYSTEM
K010542 SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
K010427 LORENZ FIDUCAIL SCREW
K010548 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K003699 MEDIVISION IGS SYSTEM
K003776 MICROTARGETING DRIVE SYSTEM
K003347 ORTHOPILOT
K003268 Z-TOUCH
K004027 STRYKER REMOTE SURGICAL PLANNING SYSTEM
K003111 STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES
K003201 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K002893 FLUOROLAB PLUS
K002732 STRYKER NAVIGATION SYSTEM - ENT MODULE
K001642 INSIGHT IMAGE GUIDED SURGICAL SYSTEM
K002053 NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
K001950 OPTICAL TRACKING SYSTEM (OTS)
K001801 STEATHSTATION TREATMENT GUIDANCE PLATFORM
K001284 STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
K001192 SELF ADHERING NAVIGUS GUIDE
K001431 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001153 MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
K000171 CBYON SURGICAL OPERATING SYSTEM (SOS)
K994421 SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
K992461 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K000310 VOYAGER 6.0 SOFTWARE OPTION
K993239 STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K992916 BRAINLAB STEREOTACTIC ARC
K992927 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K993673 SNN FLUORO NAVIGATION SYSTEM
K991706 VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K993501 3D1 MICROPOSITIONING HEADSTAGE
K990683 AXON MP-1 MICROPOSITIONER
K992843 THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
K991256 VIEWPOINT ENT/ORTHOPEDIC OPTION
K992882 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
K983410 @ TARGET
K992721 COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992457 SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
K992304 NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K990907 REMOTE INTRODUCER, MODEL PI-1000
K991636 ELEKTA STEREOTACTIC GUIDE
K991267 SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
K983764 VIEWPOINT TOOLS- STERRAD
K991081 FRAMELESS NEUROMATE
K984298 Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
K983831 VECTORVISION2
K990632 OPTICAL TRACKING SYSTEM (OTS)
K990214 FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
K990868 VIEWPOINT PASSIVE TOOL OPTION
K990860 VIEWPOINT MICROSCOPE OPTION
K990326 OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
K983539 TRAJECTORY GUIDE, MODEL # TGX-XXX
K981480 PHILIPS EASYGUIDE
K983670 STEALTHSTATION SYSTEM
K982570 SNN SCOUT
K984245 NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
K983397 STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
K981768 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K983669 OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
K983603 REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K981508 VECTORVISION SPINE MODULE
K980820 PHILIPS EASYGUIDE
K982244 MAYFIELD ACCISS OPTICAL SYSTEM
K961903 MAGELLAN
K981809 CAROLINE GUIDE
K981686 STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981684 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K982364 WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K981315 NAVITRACK
K981213 UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K980584 ATLASPLAN
K974602 OPTICAL TRACKING SYSTEM (OTS)
K973684 LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K972324 LEKSELL STEREOTACTIC SYSTEM
K974187 STEALTHSTATION SYSTEM
K974161 STEALTHSTATION SYSTEM
K973277 CAROLINE GUIDE/DELIA LOCALIZER
K972398 STEALTHSTATION PASSIVE INSTRUMENT OPTION
K964229 REGULUS NAVIGATOR
K971675 SNT STEREOTACTIC LOCALIZATION SYSTEM
K971247 SNT DISPOSABLE BIOPSY NEEDLE
K970865 ISG FAMILY OF VIEWING WANDS
K964801 OPTICAL TRACKING SYSTEM (OTS)
K962939 VECTORVISION
K970604 VIEWPOINT - 3.0 SOFTWARE
K963256 NEUROMATE STEREOTACTIC SYSTEM
K965139 SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K963221 OPTICAL DIGITIZER OPTION FOR VIEW POINT
K961834 PHILIPS EASYGUIDE NEURO
K963173 STEALTHSTATION SYSTEM
K961844 OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
K954789 BRAINLAB HEADPINS
K961858 COSGROVE DEPTH ELECTRODE KIT(CDEK)
K961639 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
K960714 ISG VIEWING WAND
K961120 MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
K955397 MAYFIELD-ACCISS WORKSTATION
K953568 CODMAN FIDUCIAL MARKER SYSTEM
K952390 BRAINLAB STEROTATIC HEADRING
K954276 STEALTHSTATION
K944463 CRW-1 SYSTEM
K935456 REGULUS MEASUREMENT UNIT
K946033 LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE
K946252 STEREOPLAN
K943468 LEKSELL SURGIPLAN
K936019 NOMOS STEREOTACTIC BIOPSY INSTRUMENTS
K931991 GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K924348 AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
K915791 CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION
K915819 BRAINSCAN WORKSTATION
K901883 STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
K901670 GNOMOS STEREOTACTIC DEVICE
K900200 COOK STEREOTAXIC GUIDE
K894387 WESTCO MADAYAG PAB NEEDLE
K894263 CASS SYSTEM
K881132 LAITINEN'S TRIGEMINUS STEREOGUIDE
K881131 THE LAITINEN STEREOTACTIC SYSTEM
K874693 OBT STEREOTACTIC SYSTEM
K874833 ARC ADAPTER ASSEMBLY
K872877 TARGET PROGRAM & EPSON HX-20 COMPUTER
K871046 COMPASS STEREOTACTIC POSITIONING SYSTEM
K861629 KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
K862220 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
K854475 GHAJAR INTRAVENTRICULAR CATHETER GUIDE
K852662 GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY
K852477 KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
K851973 DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851659 SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
K833484 COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
K830999 DAP II BIOPSY GUIDE
K831329 PMT VAXIOM STEREOTACTIC SYS #FX001
K823424 MENISCECTOMY TRAY #9715
K823675 FRONING GUIDANCE SYSTEM #TX-8200
K812744 LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER
K811452 BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM
K790502 DYONICS STEROTOXIC POSITIONER

FEI Numbers

This FDA classification entry is associated with 246 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 246 registration numbers. Click on an entry to view related FDA registrations.