510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+8K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+8K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+8K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+8K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+8K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+8K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+8K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+8K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+8K161999AixplorerSupersonic Imagine201620—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+8K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+8K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+8K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+8K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+8K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+8K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+8K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+8K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+8K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+8K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+8K140677MylabssognoEsaote, S.p.A.20140—
+8K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+8K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+8K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+8K132274AixplorerSupersonic Imagine2013312—
+8K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+8K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+8K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+8K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+8K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+8K111142Echosoft (TM)Echometrix, LLC20120—
+8K112255AixplorerSupersonic Imagine2012525—
+8K121384MylabsognoEsaote, S.p.A.201211
+8K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+8K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+8K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+8K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+8K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+8K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+8K110688MylabgoldEsaote2011251
+8K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+8K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+8K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+8K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+8K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+8K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+8K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+8K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+8K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+8K083421MR-Touch OptionGe Medical Systems, LLC20094—
+9K260748ES-SeriesE-Scopics20260—
+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—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+9K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+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—
+9K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K220956Libby Echo:PrioDyad Medical, Inc.20221—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+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—
+9K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+9K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+9K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+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—
+9K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+9K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+9K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+9K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+9K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K193518KosmosEchoNous, Inc.20201—
+9K192372ASCEND Image ViewerAscend Hit20200—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+9K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—