510(k) Report

Devices descending from K032111

955 later devices reach Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+9K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+9K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K200603AAA ModelPhilips Ultrasound, Inc.20200—
+9K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+9K200655FibroScan® 630Echosens20200—
+9K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+9K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+9K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+9K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+9K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+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—
+9K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+9K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+9K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+9K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+9K173569Ultrasound System 1300Bk Medical Aps20181—
+9K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+9K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+9K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+9K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+9K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+9K163443Interson USB Ultrasound SystemInterson Corporation20173—
+9K170445Logiq S8GE Healthcare2017191
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+9K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+9K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+9K162549Lumify Ultrasound SystemPhilips Health Care2016436
+9K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+9K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+9K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+9K160357TrinityKoelis20161—
+9K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+9K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+9K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+9K160420SpeqTSignostics Limited20161—
+9K160524FibroScan 530 CompactEchosens201641—
+9K160182LOGIQ S7 ExpertGE Healthcare2016361
+9K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+9K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+9K143452Logiq P9, Logiq P7GE Healthcare2015131—
+9K141639Voluson S6, Voluson S8GE Healthcare2014151—
+9K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+9K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+9K133533Logiq EGE Healthcare2014149—
+9K133034Logiq F SeriesGE Healthcare2014155—
+9K133431VENUE 50GE Healthcare201360—
+9K131937Voluson I/EGE Healthcare201335—
+9K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+9K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+9K1311184D VIEWGE Healthcare20131—
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K122387Voluson P6, Voluson P8GE Healthcare2012201—
+9K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+10K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+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—
+10K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K2503303mensio WorkstationPie Medical Imaging BV202501
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+10K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—