FDA Product Code
FDA Product Code HAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 425 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K002893 | FLUOROLAB PLUS | Z-Kat, Inc. | 2000-12-04 | Traditional | PDF ↗ |
| K002732 | STRYKER NAVIGATION SYSTEM - ENT MODULE | Stryker Corp. | 2000-10-02 | Traditional | PDF ↗ |
| K001642 | INSIGHT IMAGE GUIDED SURGICAL SYSTEM | Surgical Insights, Inc. | 2000-09-12 | Traditional | PDF ↗ |
| K002053 | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 | Orthosoft, Inc. | 2000-08-03 | Special | PDF ↗ |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 2000-07-26 | Special | PDF ↗ |
| K001801 | STEATHSTATION TREATMENT GUIDANCE PLATFORM | Medtronic Surgical Navigation | 2000-06-30 | Special | PDF ↗ |
| K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | Medtronic Surgical Navigation Technologies | 2000-06-12 | Traditional | PDF ↗ |
| K001192 | SELF ADHERING NAVIGUS GUIDE | Image-Guided Neurologics, Inc. | 2000-06-07 | Traditional | PDF ↗ |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 2000-05-17 | Special | PDF ↗ |
| K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM | Medtronic Surgical Navigation | 2000-05-03 | Special | PDF ↗ |
| K000171 | CBYON SURGICAL OPERATING SYSTEM (SOS) | Cbyon, Inc. | 2000-03-13 | Traditional | PDF ↗ |
| K994421 | SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION | Surgical Navigation Specialists, Inc. | 2000-02-23 | Traditional | PDF ↗ |
| K992461 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 2000-02-22 | Traditional | PDF ↗ |
| K000310 | VOYAGER 6.0 SOFTWARE OPTION | Philips Medical Systems (Cleveland), Inc. | 2000-02-15 | Special | PDF ↗ |
| K993239 | STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX | Stryker Corp. | 2000-01-18 | Traditional | PDF ↗ |
| K992916 | BRAINLAB STEREOTACTIC ARC | Brainlab | 2000-01-11 | Traditional | PDF ↗ |
| K992927 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1999-12-29 | Traditional | PDF ↗ |
| K993673 | SNN FLUORO NAVIGATION SYSTEM | I.S.G. Technologies, Inc. | 1999-12-21 | Traditional | PDF ↗ |
| K991706 | VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE | Stryker Corp. | 1999-12-07 | Traditional | PDF ↗ |
| K993501 | 3D1 MICROPOSITIONING HEADSTAGE | Scientific Tools, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K990683 | AXON MP-1 MICROPOSITIONER | Axon Instruments, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K992843 | THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F | Ohio Medical Instrument Co., Inc. | 1999-11-02 | Traditional | PDF ↗ |
| K991256 | VIEWPOINT ENT/ORTHOPEDIC OPTION | Philips Medical Systems (Cleveland), Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992882 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT | Elekta Instrument AB | 1999-09-24 | Special | PDF ↗ |
| K983410 | @ TARGET | Brainlab AG | 1999-09-17 | Traditional | PDF ↗ |
| K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE | Radionics, Inc. | 1999-09-10 | Special | PDF ↗ |
| K992304 | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX | Image-Guided Neurologics, Inc. | 1999-08-27 | Traditional | PDF ↗ |
| K992457 | SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION | Surgical Navigation Specialists, Inc. | 1999-08-27 | Traditional | PDF ↗ |
| K990907 | REMOTE INTRODUCER, MODEL PI-1000 | Image-Guided Neurologics, Inc. | 1999-08-12 | Traditional | PDF ↗ |
| K991636 | ELEKTA STEREOTACTIC GUIDE | Elekta Instrument AB | 1999-07-20 | Traditional | PDF ↗ |
| K991267 | SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A | Ohio Medical Instrument Co., Inc. | 1999-07-12 | Traditional | PDF ↗ |
| K983764 | VIEWPOINT TOOLS- STERRAD | Philips Medical Systems (Cleveland), Inc. | 1999-07-08 | Traditional | PDF ↗ |
| K991081 | FRAMELESS NEUROMATE | Integrated Surgical Systems, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI | Z-Kat, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K983831 | VECTORVISION2 | Brainlab AG | 1999-05-19 | Traditional | PDF ↗ |
| K990632 | OPTICAL TRACKING SYSTEM (OTS) | Radionics, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-04-22 | Traditional | PDF ↗ |
| K990868 | VIEWPOINT PASSIVE TOOL OPTION | Philips Medical Systems (Cleveland), Inc. | 1999-03-30 | Special | PDF ↗ |
| K990860 | VIEWPOINT MICROSCOPE OPTION | Philips Medical Systems (Cleveland), Inc. | 1999-03-30 | Special | PDF ↗ |
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | Radionics Software Applications, Inc. | 1999-03-04 | Special | PDF ↗ |
| K983539 | TRAJECTORY GUIDE, MODEL # TGX-XXX | Image-Guided Neurologics, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K981480 | PHILIPS EASYGUIDE | Philips Medical Systems, Inc. | 1999-01-28 | Traditional | PDF ↗ |
| K983670 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1999-01-14 | Traditional | PDF ↗ |
| K982570 | SNN SCOUT | I.S.G. Technologies, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K984245 | NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS | Radionics, Inc. | 1998-12-18 | Special | PDF ↗ |
| K983397 | STEALTHSTATION TREATMENT GUIDANCE PLAFFORM | Surgical Navigation Technologies, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K981768 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1998-11-23 | Traditional | PDF ↗ |
| K983669 | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS | Radionics, Inc. | 1998-11-18 | Special | PDF ↗ |
| K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME | Radionics, Inc. | 1998-11-10 | Special | PDF ↗ |
| K981508 | VECTORVISION SPINE MODULE | Brainlab AG | 1998-10-29 | Traditional | PDF ↗ |
| K980820 | PHILIPS EASYGUIDE | Philips Medical Systems, Inc. | 1998-10-13 | Traditional | PDF ↗ |
| K982244 | MAYFIELD ACCISS OPTICAL SYSTEM | Ohio Medical Instrument Co., Inc. | 1998-09-23 | Traditional | PDF ↗ |
| K961903 | MAGELLAN | Biosense, Ltd. | 1998-08-24 | Traditional | PDF ↗ |
| K981809 | CAROLINE GUIDE | Surgical Solutions, Inc. | 1998-08-14 | Traditional | PDF ↗ |
| K981686 | STEALTHSTATION SYSTEM DIGITIZER CHANGE | Surgical Navigation Technologies, Inc. | 1998-08-07 | Traditional | PDF ↗ |
| K981684 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM | Surgical Navigation Technologies, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K982364 | WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) | Radionics, Inc. | 1998-08-05 | Special | PDF ↗ |
| K981315 | NAVITRACK | Orthosoft, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K981213 | UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I | Radionics, Inc. | 1998-07-01 | Traditional | PDF ↗ |
| K980584 | ATLASPLAN | Radionics, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | Radionics Software Applications, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K973684 | LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND | Elekta Instrument AB | 1998-03-31 | Traditional | PDF ↗ |
| K972324 | LEKSELL STEREOTACTIC SYSTEM | Elekta Instrument AB | 1998-03-02 | Traditional | PDF ↗ |
| K974187 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1998-01-21 | Traditional | PDF ↗ |
| K974161 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K973277 | CAROLINE GUIDE/DELIA LOCALIZER | Surgical Solutions, Inc. | 1997-11-17 | Traditional | PDF ↗ |
| K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION | Surgical Navigation Technologies, Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K964229 | REGULUS NAVIGATOR | Compass Intl., Inc. | 1997-08-19 | Traditional | PDF ↗ |
| K971675 | SNT STEREOTACTIC LOCALIZATION SYSTEM | Surgical Navigation Technologies, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K971247 | SNT DISPOSABLE BIOPSY NEEDLE | Surgical Navigation Technologies, Inc. | 1997-06-16 | Traditional | PDF ↗ |
| K970865 | ISG FAMILY OF VIEWING WANDS | I.S.G. Technologies, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | Radionics Software Applications, Inc. | 1997-06-02 | Traditional | PDF ↗ |
| K962939 | VECTORVISION | Brainlab, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K970604 | VIEWPOINT - 3.0 SOFTWARE | Philips Medical Systems (Cleveland), Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K963256 | NEUROMATE STEREOTACTIC SYSTEM | Integrated Surgical Systems, S.A. | 1997-05-09 | Traditional | PDF ↗ |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Carl Zeiss, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K963221 | OPTICAL DIGITIZER OPTION FOR VIEW POINT | Philips Medical Systems (Cleveland), Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K961834 | PHILIPS EASYGUIDE NEURO | Philips Medical Systems, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K963173 | STEALTHSTATION SYSTEM | Surgical Navigation Technologies, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | Radionics Software Applications, Inc. | 1996-10-23 | Traditional | PDF ↗ |
| K954789 | BRAINLAB HEADPINS | Brainlab AG | 1996-08-12 | Traditional | PDF ↗ |
| K961858 | COSGROVE DEPTH ELECTRODE KIT(CDEK) | Radionics, Inc. | 1996-08-07 | Traditional | PDF ↗ |
| K961639 | LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) | Elekta Instrument AB | 1996-07-26 | Traditional | PDF ↗ |
| K960714 | ISG VIEWING WAND | I.S.G. Technologies, Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K961120 | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION | Howmedica Leibinger, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K955397 | MAYFIELD-ACCISS WORKSTATION | Nomos Corp. | 1996-04-30 | Traditional | PDF ↗ |
| K953568 | CODMAN FIDUCIAL MARKER SYSTEM | Codman & Shurtleff, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K952390 | BRAINLAB STEROTATIC HEADRING | Brainlab Med. Computersysteme GmbH | 1996-02-02 | Traditional | PDF ↗ |
| K954276 | STEALTHSTATION | Surgical Navigation Technologies, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K944463 | CRW-1 SYSTEM | Radionics Software Applications, Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K935456 | REGULUS MEASUREMENT UNIT | Compass Intl., Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K946033 | LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE | Leibinger GmbH | 1995-09-01 | Traditional | PDF ↗ |
| K946252 | STEREOPLAN | Radionics Software Applications, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K943468 | LEKSELL SURGIPLAN | Elekta Instruments, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K936019 | NOMOS STEREOTACTIC BIOPSY INSTRUMENTS | Nomos Corp. | 1994-03-22 | Traditional | PDF ↗ |
| K931991 | GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION | Nomos Corp. | 1993-08-20 | Traditional | PDF ↗ |
| K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC | Ad-Tech Medical Instrument Corp | 1992-11-23 | Traditional | PDF ↗ |
| K915791 | CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION | Coritechs, Inc. | 1992-07-10 | Traditional | PDF ↗ |
| K915819 | BRAINSCAN WORKSTATION | Brainlab Medizinische Computersysteme GmbH | 1992-05-11 | Traditional | PDF ↗ |
| K901883 | STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE | Stereotactic Image Systems, Inc. | 1991-03-07 | Traditional | PDF ↗ |
Product code HAW · Class II · Neurology. Data: openFDA.