510(k) Report

Devices descending from K150087

73 later devices reach Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+1K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+1K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+1K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+2K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+2K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+2K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+2K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+2K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+2K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+2K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+2K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+3K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+3K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+3K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+3K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+3K200708Vivid iqGe Medical Systems Ultrasound And20203—
+3K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+3K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+3K200138Versana PremierGe Medical Systems Ultrasound And20202—
+3K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+3K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+4K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+4K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+4K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K220851VenueGE Medical Systems20223—
+4K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+4K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+4K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+4K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+4K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K201768Voluson E10GE Healthcare20204—
+4K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+4K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+5K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+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
+5K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+5K220848Venue FitGE Medical Systems202241
+5K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+5K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+5K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+5K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+5K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+5K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+6K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+6K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+6K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+6K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+6K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+6K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+6K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+7K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+7K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+7K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+7K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+8K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+8K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—