510(k) Report

Devices descending from K032620

864 later devices reach GE Voluson 730 Pro/Expert BT03 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+5K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+5K160162Voluson P6, Voluson P8GE Healthcare201613—
+5K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+5K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+5K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K152195Logiq S8GE Healthcare201557—
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150949FibroScanEchosens201542—
+5K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+5K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+5K131527Logiq S8GE Healthcare2013219—
+5K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+5K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+5K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+5K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+5K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+5K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+5K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+5K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+5K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+5K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+5K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+5K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+6K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+6K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+6K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+6K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+6K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+6K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+6K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+6K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+6K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+6K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+6K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+6K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+6K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K200708Vivid iqGe Medical Systems Ultrasound And20203—
+6K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+6K200655FibroScan® 630Echosens20200—
+6K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+6K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+6K200138Versana PremierGe Medical Systems Ultrasound And20202—
+6K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—