510(k) Report

Devices descending from K032135

140 later devices reach Site-Rite IV Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc.2005139—
+2K070515A-View Basic and PlusCordatec N.V.20071—
+2K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc.2007136—
+3K170338A-ViewStroke2prevent B.V.20170—
+3K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201464—
+3K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+3K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+3K093713Ultrasound General Purpose Guidance SystemCivco Medical Instruments201047
+3K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+4K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.20260—
+4K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+4K203657Vu-Path Ultrasound SystemCrystalline Medical20210—
+4K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis20170—
+4K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+4K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+4K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+4K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+5K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+5K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+5K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K140254EZONO 4000Ezono AG201413—
+6K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+6K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+6K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K251673X9 Ultrasound SystemX9, Inc.20250—
+7K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+7K211527Exo IrisExo Imaging, Inc.20211—
+7K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+7K200655FibroScan® 630Echosens20200—
+7K200138Versana PremierGe Medical Systems Ultrasound And20202—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+8K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K220851VenueGE Medical Systems20223—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+8K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+8K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+9K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+9K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220848Venue FitGE Medical Systems202241
+9K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—