510(k) Report

Devices descending from K091164

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+8K170841BiopSee, Mobile USMedcom GmbH20170—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+9K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+9K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+9K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+9K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+9K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K213689Voluson P6, Voluson P8GE Healthcare20220—
+9K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+9K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+9K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+9K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+9K201768Voluson E10GE Healthcare20204—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+9K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200655FibroScan® 630Echosens20200—
+9K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+9K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+9K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+9K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+9K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+9K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+9K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+9K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+9K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+10K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+10K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+10K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+10K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+10K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+10K242223SuperSonic HepaVuSupersonic Imagine20240—
+10K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+10K230365Sonio DetectSonio20237—