510(k) Report

Devices descending from K121063

176 later devices reach Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+1K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+1K141639Voluson S6, Voluson S8GE Healthcare2014151—
+1K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+1K123894GE EchopacGe Vingmed Ultrasound AS20139—
+2K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+2K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+2K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+2K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+2K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+2K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+2K160182LOGIQ S7 ExpertGE Healthcare2016361
+2K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+2K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+2K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+2K143452Logiq P9, Logiq P7GE Healthcare2015131—
+2K131685GE EchopacGe Vingmed Ultrasound AS20138—
+3K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+3K200708Vivid iqGe Medical Systems Ultrasound And20203—
+3K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+3K200138Versana PremierGe Medical Systems Ultrasound And20202—
+3K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+3K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+3K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+3K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+3K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+3K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+3K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+3K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+3K170521Trinity/3D Prostate SuiteKoelis20170—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+3K152195Logiq S8GE Healthcare201557—
+4K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+4K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+4K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+4K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+4K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+4K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+4K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+4K211527Exo IrisExo Imaging, Inc.20211—
+4K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+4K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+4K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+4K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+4K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+4K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+4K170445Logiq S8GE Healthcare2017191
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+5K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+5K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+5K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+5K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+5K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+5K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+5K220851VenueGE Medical Systems20223—
+5K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+5K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+5K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K201768Voluson E10GE Healthcare20204—
+5K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181783Logiq P9; Logiq P7GE Healthcare2018171
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+6K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+6K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+6K220848Venue FitGE Medical Systems202241
+6K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+6K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+6K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+6K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+6K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—