510(k) Report

Devices descending from K032111

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+8K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+8K1808835D ViewerSamsung Medison Co., Ltd.20180—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+8K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+8K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+8K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+8K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+8K1725133D EchoJointvue, LLC20171—
+8K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+8K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K170841BiopSee, Mobile USMedcom GmbH20170—
+8K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+8K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+8K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+8K163505Arietta PrecisionHitachi, Ltd.20170—
+8K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+8K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+8K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+8K162583Aloka Lisendo 880Hitachi, Ltd.201602
+8K163020Xperius Ultrasound SystemPhilips Health Care201611
+8K161960bk2300Bk Medical Aps20165—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+8K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+8K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+8K152195Logiq S8GE Healthcare201557—
+8K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+8K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+8K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+8K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+8K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+8K150949FibroScanEchosens201542—
+8K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+8K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+8K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+8K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+8K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+8K131527Logiq S8GE Healthcare2013219—
+8K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+8K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+8K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+8K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+8K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+8K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+8K120741Voluson S6, Voluson S8GE Healthcare2012295—
+8K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+9K251417ReVISION 2Argus Cognitive, Inc.20260—
+9K260192DIANAROPCA ApS20260—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+9K250120GECHONarnar, LLC20250—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+9K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+9K243479EchoGuide (Version 1)Sonavex, Inc.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—
+9K242359Strain AI (SAI001)Exo, Inc.20240—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+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—
+9K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+9K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K232501AI Platform (AIP001)Exo, Inc.20231—
+9K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+9K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+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—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+9K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+9K212376Caas QardiaPie Medical Imaging BV20220—
+9K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+9K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+9K213275EchoGo Core (2.0)Ultromics Limited20211—