510(k) Report

Devices descending from K981998

327 later devices reach Pediatric Instatrak System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended…Visualization Technology, Inc.19990Class I
+1K983529Instatrak 3000Visualization Technology, Inc.1998325Class I
+1K982994Skull Base Instatrak SystemVisualization Technology, Inc.1998280Class I
+2K151414IQQA GuideEdda Technology20151—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K121498PercunavPhilips Health Care2012222—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc.200611—
+2K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc.2000294Class I
+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—
+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—
+3K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+3K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+3K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems20022Class I
+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
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+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—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+4K160369GuideWireFiagon GmbH20163—
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+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—
+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—
+4K141855ClarityElekta, Ltd.20140—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K041931Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc.200415
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+5K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171677Clear Guide SCENERGYClear Guide Medical20173—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—