510(k) Report

Devices descending from K092079

331 later devices reach Modification to GE Vivid S5 and S6 Diagnostic Ultrasound through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102393Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound SystemGe Medical System Israel, Ltd.20101772
+1K102388Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20102842
+1K101324GE Echopac Model BT10Ge Vingmed Ultrasound AS2010172—
+1K102104GE Vivid P3 Diagnostic Ultrasound Imaging SystemWipro GE Healthcare Private, Ltd.20101—
+2K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic ScannerBeijing East Whale Imaging Technology Co., Ltd.20160—
+2K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121762
+2K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121101
+2K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+2K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20122531
+2K120221GE EchopacGE Healthcare2012170—
+2K112371Logiq P3GE Healthcare20110—
+3K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+3K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+3K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+3K141639Voluson S6, Voluson S8GE Healthcare2014151—
+3K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+3K123894GE EchopacGe Vingmed Ultrasound AS20139—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+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—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+4K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+4K160182LOGIQ S7 ExpertGE Healthcare2016361
+4K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+4K152195Logiq S8GE Healthcare201557—
+4K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+4K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+4K143452Logiq P9, Logiq P7GE Healthcare2015131—
+4K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+4K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+4K131685GE EchopacGe Vingmed Ultrasound AS20138—
+5K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+5K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+5K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+5K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+5K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+5K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+5K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+5K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+5K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+5K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+5K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+5K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+5K170521Trinity/3D Prostate SuiteKoelis20170—
+5K163690DC-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—
+5K170445Logiq S8GE Healthcare2017191
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+5K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+5K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+5K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—