510(k) Report

Devices descending from K042770

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+7K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+7K123806FibroscanEchosens201355—
+7K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+7K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+7K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K111582Logiq S8GE Healthcare20113673
+7K110943Logiq E9GE Healthcare20114722
+7K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K103649Voluson S6, Voluson S8GE Healthcare2011296—
+7K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+7K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+7K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+7K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+8K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+8K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+8K220956Libby Echo:PrioDyad Medical, Inc.20221—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+8K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+8K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K201693DC-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—
+8K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+8K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+8K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+8K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+8K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+8K193518KosmosEchoNous, Inc.20201—
+8K192372ASCEND Image ViewerAscend Hit20200—
+8K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+8K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+8K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+8K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+8K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+8K1808835D ViewerSamsung Medison Co., Ltd.20180—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+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—
+8K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K170841BiopSee, Mobile USMedcom GmbH20170—
+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—
+8K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+8K162583Aloka Lisendo 880Hitachi, Ltd.201602
+8K163020Xperius Ultrasound SystemPhilips Health Care201611
+8K161960bk2300Bk Medical Aps20165—
+8K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+8K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+8K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+8K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+8K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+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