510(k) Report

Devices descending from K001284

751 later devices reach Stealthstation System Goldeneye Micro-Magnetic Tracking System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.201618
+1K153247Fusion Compact Navigation SystemMedtronic Navigation, Inc.20164—
+1K141833Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…Medtronic Navigation, Inc.201532
+1K133573Fiagon Navigation SystemFiagon GmbH201428—
+1K133665Malleable Suction InstrumentsMedtronic Navigation, Inc.201414—
+1K130608QuadcutMedtronic Navigation, Inc.2013171
+1K060903IG4 Image Guided SystemVeran Medical Technologies, Inc.200647—
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K014256Kolibri Igs SystemsBrainlab AG2002419—
+2K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated…Medtronic Xomed, Inc.20260—
+2K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+2K221037TruDi Shaver BladeAcclarent, Inc.20220—
+2K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+2K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.20202—
+2K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+2K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+2K163209Fiagon Navigation SystemFiagon GmbH20170—
+2K170018StealthStationTM S8 ENT SoftwareMedtronic Navigation, Inc.20173—
+2K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+2K162176Fiagon Navigation SystemFiagon GmbH20164—
+2K161701CARTO ENT SystemBiosense Webster20163—
+2K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+2K152473CAS-One IRCascination AG20163—
+2K151414IQQA GuideEdda Technology20151—
+2K150473FlexPointer 1.5 mmFiagon GmbH20152—
+2K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K132108MAXIOPerfint Healthcare Pvt, Ltd.201427—
+2K121498PercunavPhilips Health Care2012222—
+2K122096Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc.20125—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K110021Dash HipBrainlab AG201147—
+2K110812CT-Guide Needle Guidance SystemActiviews, Ltd.20112—
+2K102251Dash KneeBrainlab AG201110—
+2K093995IG 4 Image Guided SystemVeran Medical Technologies, Inc.20102—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K091934IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Veran Medical Technologies, Inc.20092—
+2K093146IG4 Image Guided System, Model: Sys-0200Veran Medical Technologies, Inc.200935
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+2K042721Kolibri SpineBrainlab AG2005187—
+2K042391Kolibri Image Guided Surgery SystemBrainlab AG200472—
+2K031770CI TKR/UkrBrainlab AG2003134—
+3K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+3K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.20260—
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K232022CAS-One IRCascination AG20241—
+3K223758EpioneQuantum Surgical Sas202302
+3K223734ENT EMBrainlab AG20230—
+3K213989Cranial EM SystemBrainlab AG20221—
+3K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+3K220652Knee 3Brainlab AG20220—
+3K211645EpioneQuantum Surgical Sas20221—
+3K201174TruDi CuretteAcclarent, Inc.20200—
+3K193453TruDi ProbeAcclarent, Inc.20200—
+3K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+3K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+3K192397TruDi Navigation SystemBiosense Webster202011
+3K191332XACT Robotic SystemXact Robotics, Ltd.20193—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+3K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+3K163643Sirio H3Masmec Spa20170—
+3K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+3K163439NaviENTClaronav, Inc.20171—
+3K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+3K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+3K160369GuideWireFiagon GmbH20163—
+3K150313Ablation ConfirmationNeuwave Medical, Inc.201516—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+3K140331Orthalign Plus SystemOrthalign, Inc.201429—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K132087Percunav SystemPhilips Health Care20139—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K121479AIMInneroptic Technology, Inc.20125—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K120300CT-Guide Needle Guidance SystemActiviews, Ltd.20120—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K113063CT-Guide Needle Guidance SystemActiviews, Ltd.20111—
+3K110204Brainlab TraumaBrainlab AG201127—
+3K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K082060Cranial Image Guided Surgery SystemBrainlab AG200916—
+3K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K072716Vector Vision HipBrainlab AG200784—