510(k) Report

Devices descending from K161047

107 later devices reach LOGIQ P9 and LOGIQ P7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+1K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+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—
+2K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+2K181783Logiq P9; Logiq P7GE Healthcare2018171
+2K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+2K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+2K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+2K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+2K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+3K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+3K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+3K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+3K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+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—
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+3K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+3K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+3K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+4K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+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—
+4K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+4K211527Exo IrisExo Imaging, Inc.20211—
+4K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+4K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+4K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+4K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+4K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+4K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+4K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+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—
+5K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+5K220848Venue FitGE Medical Systems202241
+5K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+5K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+5K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+5K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+5K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+5K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+5K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+5K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+6K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+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
+6K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+6K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+6K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+6K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+6K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+6K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+6K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+6K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+7K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+7K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+7K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+7K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+7K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+7K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+8K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+8K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+8K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+9K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+9K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—