510(k) Report

Devices descending from K954276

549 later devices reach Stealthstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+1K093494Linasys Image-Guided Liver Surgery SystemPathfinder Therapeutics, Inc.20102—
+1K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+1K071063LinasysPathfinder Therapeutics, Inc.200710—
+1K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN2004280Class I
+1K013025Modification to Flourolab PlusZ-Kat, Inc.2001151—
+1K992461Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc.2000279—
+1K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999152—
+1K990632Optical Tracking System (Ots)Radionics, Inc.19990—
+1K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+1K983529Instatrak 3000Visualization Technology, Inc.1998325Class I
+1K984398Liquichek Ana Control, Homogeneous Pattern, Model 201Bio-Rad19980—
+1K983669Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc.19980—
+1K980820Philips EasyguidePhilips Medical Systems, Inc.19980—
+1K981686Stealthstation System Digitizer ChangeSurgical Navigation Technologies, Inc.1998281—
+1K974602Optical Tracking System (Ots)Radionics Software Applications, Inc.19982—
+1K974161Stealthstation SystemSurgical Navigation Technologies, Inc.1997279—
+1K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973—
+1K964801Optical Tracking System (Ots)Radionics Software Applications, Inc.19973—
+1K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB19962—
+1K961168ViewpointPhilips Medical Systems (Cleveland), Inc.1996161—
+2K151414IQQA GuideEdda Technology20151—
+2K143024CAS-One LiverCascination AG20150—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K121498PercunavPhilips Health Care2012222—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K091000KneekgEmovi20090—
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc.200611—
+2K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+2K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—
+2K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+2K013428Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss SystemOhio Medical Instrument Co., Inc.20021—
+2K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc.2000294Class I
+2K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended…Visualization Technology, Inc.19990Class I
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981—
+2K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc.1997159—
+2K963221Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc.1997160—
+3K203722RayPilot SystemMicropos Medical AB20210—
+3K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+3K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+3K162176Fiagon Navigation SystemFiagon GmbH20164—
+3K161701CARTO ENT SystemBiosense Webster20163—
+3K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K150473FlexPointer 1.5 mmFiagon GmbH20152—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132087Percunav SystemPhilips Health Care20139—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K121663ClarityElekta, Ltd.20121—
+3K123137Calypso SystemVarian Medical Systems20123—
+3K121479AIMInneroptic Technology, Inc.20125—
+3K111863Signature Planner,Signature GuidesMaterialise NV201271—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+3K110911Renaissance SystemMazor Robotics, Ltd.201124—
+3K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+3K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+3K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+3K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+3K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K041897Mayfield Acciss II Image Guided Surgery System, Model 2002-01Schaerer Mayfield USA, Inc.20050—
+3K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+3K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems20022Class I
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB19990—
+3K983764Viewpoint Tools- SterradPhilips Medical Systems (Cleveland), Inc.19990—
+3K990868Viewpoint Passive Tool OptionPhilips Medical Systems (Cleveland), Inc.19991—
+3K990860Viewpoint Microscope OptionPhilips Medical Systems (Cleveland), Inc.19990—
+4K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193453TruDi ProbeAcclarent, Inc.20200—
+4K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K192397TruDi Navigation SystemBiosense Webster202011
+4K182359HipCheckStryker Corp.20181—
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+4K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—