510(k) Report

Devices descending from K062247

687 later devices reach HD11 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152195Logiq S8GE Healthcare201557—
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+5K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+5K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+5K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+5K143452Logiq P9, Logiq P7GE Healthcare2015131—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+5K141639Voluson S6, Voluson S8GE Healthcare2014151—
+5K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+5K133533Logiq EGE Healthcare2014149—
+5K133034Logiq F SeriesGE Healthcare2014155—
+5K133431VENUE 50GE Healthcare201360—
+5K131937Voluson I/EGE Healthcare201335—
+5K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+5K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+5K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+5K1311184D VIEWGE Healthcare20131—
+5K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+5K122387Voluson P6, Voluson P8GE Healthcare2012201—
+5K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+6K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+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—
+6K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+6K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+6K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+6K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+6K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K223830Ultrasound System 2300Bk Medical Aps202306
+6K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+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—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K200655FibroScan® 630Echosens20200—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+6K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+6K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+6K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+6K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+6K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+6K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+6K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+6K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+6K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K170521Trinity/3D Prostate SuiteKoelis20170—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K163690DC-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—
+6K170445Logiq S8GE Healthcare2017191
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—