510(k) Report

Devices descending from K051139

979 later devices reach Acuson Sequoia Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K250120GECHONarnar, LLC20250—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K243937Accuro 3SRivanna Medical, Inc.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+7K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+7K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+7K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+7K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+7K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K213275EchoGo Core (2.0)Ultromics Limited20211—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+7K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+7K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+7K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+7K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+7K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+7K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+7K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+7K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+7K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+7K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+7K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+7K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+7K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+7K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+7K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+7K190206DC-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—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+7K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+7K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+7K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+7K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+7K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+7K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+7K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+7K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+7K1725133D EchoJointvue, LLC20171—
+7K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+7K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+7K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+7K163505Arietta PrecisionHitachi, Ltd.20170—
+7K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—