510(k) Report

Devices descending from K101149

350 later devices reach GE Vivid E9 Diagnostic Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131527Logiq S8GE Healthcare2013219—
+1K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121762
+1K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121101
+1K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20122531
+2K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+2K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+2K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+2K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+2K152195Logiq S8GE Healthcare201557—
+2K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+2K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+2K141639Voluson S6, Voluson S8GE Healthcare2014151—
+2K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+2K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+2K133533Logiq EGE Healthcare2014149—
+2K133034Logiq F SeriesGE Healthcare2014155—
+2K133431VENUE 50GE Healthcare201360—
+2K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+2K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+2K123894GE EchopacGe Vingmed Ultrasound AS20139—
+3K250955XC11 ICE System, USAYorlabs, Inc.20250—
+3K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+3K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+3K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+3K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+3K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+3K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+3K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+3K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+3K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+3K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+3K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+3K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+3K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+3K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+3K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+3K170445Logiq S8GE Healthcare2017191
+3K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+3K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+3K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+3K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+3K160357TrinityKoelis20161—
+3K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+3K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+3K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+3K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+3K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+3K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+3K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+3K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+3K143601U-LiteSonoscanner Sarl20153—
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+3K143452Logiq P9, Logiq P7GE Healthcare2015131—
+3K141768Logiq V5/Logiq V3GE Healthcare201457—
+3K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K131685GE EchopacGe Vingmed Ultrasound AS20138—
+4K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+4K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+4K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+4K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+4K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+4K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+4K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+4K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+4K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+4K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+4K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+4K200708Vivid iqGe Medical Systems Ultrasound And20203—
+4K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K200138Versana PremierGe Medical Systems Ultrasound And20202—
+4K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+4K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+4K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+4K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+4K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+4K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+4K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+4K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K173555Logiq E10GE Healthcare2017382
+4K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+4K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+4K171164U-Lite EXPSonoscanner20172—
+4K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+4K170521Trinity/3D Prostate SuiteKoelis20170—
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—