510(k) Report

Devices descending from K032114

1,003 later devices reach Sequoia 8.0 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K254021Accuro XVRivanna Medical, Inc.20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K251456BrightHeart View ClassifierBrightheart20250—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+9K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+9K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+9K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+9K212012Follicle ClarityCycle Clarity20221—
+9K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+9K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+9K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+9K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K2013523D Auto LAAPhilips Health Care20200—
+9K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+9K200356Medo AriaMedo.Ai20203—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192152DC-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—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+9K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+9K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+9K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+9K190206DC-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—
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+9K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+9K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+9K1808835D ViewerSamsung Medison Co., Ltd.20180—
+9K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+9K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+9K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+9K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+9K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+9K1725133D EchoJointvue, LLC20171—
+9K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+9K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+9K170841BiopSee, Mobile USMedcom GmbH20170—
+9K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+9K163505Arietta PrecisionHitachi, Ltd.20170—
+9K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+9K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+9K162583Aloka Lisendo 880Hitachi, Ltd.201602
+9K163020Xperius Ultrasound SystemPhilips Health Care201611
+9K161960bk2300Bk Medical Aps20165—