510(k) Report

Devices descending from K060907

97 later devices reach Karl Storz Video Gastroscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+1K093779Clearpath UgiEasyglide, Ltd.201010—
+2K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+2K113050Clearpath Lower GIEasyglide, Ltd.20128—
+2K113166Clearpath Upper GIEasyglide, Ltd.20120—
+3K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+3K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+3K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+3K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+4K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+4K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+4K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+4K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K211527Exo IrisExo Imaging, Inc.20211—
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+5K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+5K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+5K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+5K181437Pure Vu SystemMotus GI Medical Technologies, Ltd.20185—
+6K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+6K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+6K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+6K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+6K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+6K220851VenueGE Medical Systems20223—
+6K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+6K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+6K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+6K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K201768Voluson E10GE Healthcare20204—
+6K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+6K200138Versana PremierGe Medical Systems Ultrasound And20202—
+6K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+6K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+6K191220Pure Vu SystemMotus GI Medical Technologies, Ltd.20194—
+7K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+7K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+7K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+7K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+7K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+7K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+7K220848Venue FitGE Medical Systems202241
+7K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+7K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+7K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20222—
+7K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+7K210981Pure Vu SystemMotus GI Medical Technologies, Ltd.20210—
+7K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+7K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+8K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+8K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+8K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20231—
+8K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+8K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+8K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+9K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+9K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—