510(k) Report

Devices descending from K091164

605 later devices reach GE Venue 40, Model 5324338 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+5K160420SpeqTSignostics Limited20161—
+5K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+5K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+5K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K143601U-LiteSonoscanner Sarl20153—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K143452Logiq P9, Logiq P7GE Healthcare2015131—
+5K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141768Logiq V5/Logiq V3GE Healthcare201457—
+5K141639Voluson S6, Voluson S8GE Healthcare2014151—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K131937Voluson I/EGE Healthcare201335—
+5K131527Logiq S8GE Healthcare2013219—
+5K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+5K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+5K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K122387Voluson P6, Voluson P8GE Healthcare2012201—
+6K253452Accuro 3SRivanna Medical, Inc.20260—
+6K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+6K254021Accuro XVRivanna Medical, Inc.20260—
+6K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+6K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K233734Interson USB Ultrasound SystemInterson Corporation20230—
+6K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+6K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+6K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+6K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+6K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+6K212100KosmosEchoNous, Inc.202101
+6K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+6K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+6K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+6K200138Versana PremierGe Medical Systems Ultrasound And20202—
+6K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+6K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+6K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+6K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+6K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+6K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+6K181574UscanEchoNous, Inc.20180—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+6K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171164U-Lite EXPSonoscanner20172—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+6K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+6K161999AixplorerSupersonic Imagine201620—
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—