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
+3K062086NavivisionBrainlab AG200677—
+3K053159Vectorvision SpineBrainlab AG20061551
+3K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+3K060468Vectorvision HipBrainlab AG2006154—
+3K052966CI Knee, CI MI TKRBrainlab AG200654—
+3K041899Vectorvision Uni-KneeBrainlab AG2004133—
+4K261225CAS-One IRCascination AG20260—
+4K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+4K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav20250—
+4K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+4K202297Aline Ablation IntelligenceMirada Medical, Ltd.202011—
+4K201586XACT Robotic SystemXact Robotics, Ltd.20202—
+4K193307HIP7Brainlab AG20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K190250Microscope NavigationBrainlab AG20190—
+4K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+4K190532TruDi NAV WireAcclarent, Inc.20190—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K172820Microscope Navigation SoftwareBrainlab AG20181—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+4K161285Ablation ConfirmationNeuwave Medical, Inc.20163—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K143024CAS-One LiverCascination AG20150—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K141806Clear Guide OneClear Guide Medical20142—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K100038Disposable Reflective Marker SpheresBrainlab AG201023
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+4K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+4K080678Uni-Knee 2.0Brainlab AG20081—
+4K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+4K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+4K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+4K070106VV Fluoro 3DBrainlab AG2007119Class I
+4K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K231897NeuroAlign softwareMedivis, Inc.20250—
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240796myAblation Guide (VB80A)Siemens Healthcare GmbH20241—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K232140OTS HipOrtoma AB202421
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K222938Ablation-fitR.a.W. S.R.L20230—
+5K223639VisAble.IOTechsomed20232—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K213759XACT Robotic System, ACE ModelXact Robotics, Ltd.20220—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K221116XACT ACE Robotic SystemXact Robotics, Ltd.20220—
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—