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
+6K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+6K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+6K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+6K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+6K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+6K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+6K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+6K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+6K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+6K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+6K140677MylabssognoEsaote, S.p.A.20140—
+6K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+6K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+6K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+6K132274AixplorerSupersonic Imagine2013312—
+6K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+6K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+6K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+6K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+6K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+6K111142Echosoft (TM)Echometrix, LLC20120—
+6K112255AixplorerSupersonic Imagine2012525—
+6K121384MylabsognoEsaote, S.p.A.201211
+6K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+6K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+6K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+6K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+6K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+6K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+6K110688MylabgoldEsaote2011251
+6K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+6K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+6K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+6K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+6K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+6K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+6K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+6K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+6K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+6K083421MR-Touch OptionGe Medical Systems, LLC20094—
+7K260748ES-SeriesE-Scopics20260—
+7K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+7K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+7K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+7K220956Libby Echo:PrioDyad Medical, Inc.20221—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+7K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+7K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+7K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+7K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+7K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+7K201693DC-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—
+7K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+7K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+7K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+7K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+7K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+7K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+7K193518KosmosEchoNous, Inc.20201—
+7K192372ASCEND Image ViewerAscend Hit20200—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+7K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+7K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+7K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+7K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—