510(k) Report

Devices descending from K022126

463 later devices reach Catheter Introducer for the Stealthstation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141833Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer…Medtronic Navigation, Inc.201532
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K042391Kolibri Image Guided Surgery SystemBrainlab AG200472—
+1K033223Zimmer Ortho Guidance Systems- Hip InstrumentsZimmer, Inc.2004133—
+1K033011Zimmer Ortho Guidance Systems- Knee InstrumentsZimmer, Inc.2004133—
+2K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+2K213989Cranial EM SystemBrainlab AG20221—
+2K163209Fiagon Navigation SystemFiagon GmbH20170—
+2K151414IQQA GuideEdda Technology20151—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+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
+2K082060Cranial Image Guided Surgery SystemBrainlab AG200916—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K062228Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless InstrumentationZimmer, Inc.20060—
+2K060556Brigit Surgical DeviceZimmer, Inc.2006128—
+2K052425Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee InstrumentationZimmer, Inc.2005130—
+2K052178Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc.20052—
+2K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+3K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—
+3K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+3K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+3K190250Microscope NavigationBrainlab AG20190—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K172820Microscope Navigation SoftwareBrainlab AG20181—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K140689Iknee Distal Femoral Cutting GuideEvergreen Orthopedic Research Lab20140—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+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—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K100038Disposable Reflective Marker SpheresBrainlab AG201023
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+3K092239Rosa Surgical Device, Model Rosa 1.1Medtech S.A20091279
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K071135Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc.20070—
+3K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+3K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+4K231897NeuroAlign softwareMedivis, Inc.20250—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+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—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K161999AixplorerSupersonic Imagine201620—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+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—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering20110—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+4K103192Navigation Marker, Reflective Marker SpheresIlumark GmbH20111—
+4K101791Rosa Surgical DeviceMedtech S.A.S201012612
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+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—
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—