510(k) Report

Devices descending from K002258

399 later devices reach Ultraguide CT-Guide 1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+1K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+1K060903IG4 Image Guided SystemVeran Medical Technologies, Inc.200647—
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K022354Ultraguide CTG 2000SAUltraguide, Ltd.2002354—
+1K013150MR-Guide 2000Ultraguide, Ltd.2001279—
+2K152473CAS-One IRCascination AG20163—
+2K151414IQQA GuideEdda Technology20151—
+2K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+2K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K132108MAXIOPerfint Healthcare Pvt, Ltd.201427—
+2K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+2K121498PercunavPhilips Health Care2012222—
+2K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+2K110812CT-Guide Needle Guidance SystemActiviews, Ltd.20112—
+2K090754LipocontrolOsyris Medical20110—
+2K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+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
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K042438Superdimension/BronchusSuperdimension, Ltd.2004731
+3K232022CAS-One IRCascination AG20241—
+3K223758EpioneQuantum Surgical Sas202302
+3K211645EpioneQuantum Surgical Sas20221—
+3K191332XACT Robotic SystemXact Robotics, Ltd.20193—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K163643Sirio H3Masmec Spa20170—
+3K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K150313Ablation ConfirmationNeuwave Medical, Inc.201516—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K140254EZONO 4000Ezono AG201413—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132087Percunav SystemPhilips Health Care20139—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K122106Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath…Veran Medical Technologies, Inc.2012113
+3K121479AIMInneroptic Technology, Inc.20125—
+3K120300CT-Guide Needle Guidance SystemActiviews, Ltd.20120—
+3K113063CT-Guide Needle Guidance SystemActiviews, Ltd.20111—
+3K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+3K090095Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20097—
+3K080581VB Image ViewerOlympus Medical Systems Corporation20082—
+3K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+3K052260Superdimension/Bronchus 4.1Superdimension, Ltd.2005562
+3K051585F-400 SystemMauna Kea Technologies200513—
+4K261225CAS-One IRCascination AG20260—
+4K260009LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Medical, Inc.20260—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K202297Aline Ablation IntelligenceMirada Medical, Ltd.202011—
+4K201586XACT Robotic SystemXact Robotics, Ltd.20202—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc.2017015
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K161285Ablation ConfirmationNeuwave Medical, Inc.20163—
+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—
+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—
+4K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+4K093810BF-NaviKgt, Inc.20101—
+4K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc.20095—
+4K052852Superdimension/Bronchus PremiumSuperdimension, Ltd.2005551
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K240796myAblation Guide (VB80A)Siemens Healthcare GmbH20241—
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K222938Ablation-fitR.a.W. S.R.L20230—
+5K223639VisAble.IOTechsomed20232—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K213759XACT Robotic System, ACE ModelXact Robotics, Ltd.20220—
+5K221116XACT ACE Robotic SystemXact Robotics, Ltd.20220—
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—