510(k) Report

Devices descending from K122327

365 later devices reach Voluson E6/E8/E8EXPERT/E10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+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—
+4K170445Logiq S8GE Healthcare2017191
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+4K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K160357TrinityKoelis20161—
+4K160162Voluson P6, Voluson P8GE Healthcare201613—
+4K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+4K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+4K160182LOGIQ S7 ExpertGE Healthcare2016361
+4K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+4K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+4K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+4K143601U-LiteSonoscanner Sarl20153—
+4K143452Logiq P9, Logiq P7GE Healthcare2015131—
+4K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+5K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+5K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+5K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+5K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+5K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+5K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+5K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+5K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+5K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+5K211527Exo IrisExo Imaging, Inc.20211—
+5K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+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—
+5K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+5K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+5K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+5K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+5K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+5K200138Versana PremierGe Medical Systems Ultrasound And20202—
+5K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K193518KosmosEchoNous, Inc.20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+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—
+5K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+5K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K181637DC-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—
+5K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+5K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+5K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+5K180535Voluson P6 and Voluson P8GE Healthcare2018121
+5K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173555Logiq E10GE Healthcare2017382
+5K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+5K171164U-Lite EXPSonoscanner20172—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+5K170521Trinity/3D Prostate SuiteKoelis20170—
+5K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+5K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+6K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+6K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+6K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+6K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+6K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+6K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+6K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+6K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+6K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—