510(k) Report

Devices descending from K050240

927 later devices reach Modification to Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+9K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+9K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+9K212376Caas QardiaPie Medical Imaging BV20220—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+9K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+9K213275EchoGo Core (2.0)Ultromics Limited20211—
+9K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+9K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+9K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+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—
+9K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+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—
+9K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+9K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+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—
+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—
+9K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+9K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+9K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+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—
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+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
+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—
+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—
+10K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K2503303mensio WorkstationPie Medical Imaging BV202501
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K250120GECHONarnar, LLC20250—