510(k) Report

Devices descending from K041319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+9K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+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—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K2116563D Echo v1.1Jointvue, LLC20210—
+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—
+9K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+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—
+9K200655FibroScan® 630Echosens20200—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+9K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+9K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+9K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+9K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+9K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+9K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+9K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+9K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+9K173569Ultrasound System 1300Bk Medical Aps20181—
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+9K170445Logiq S8GE Healthcare2017191
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+9K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+9K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+9K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+9K160357TrinityKoelis20161—
+9K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+9K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+9K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+9K160524FibroScan 530 CompactEchosens201641—
+9K160182LOGIQ S7 ExpertGE Healthcare2016361
+9K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+9K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+9K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+9K143452Logiq P9, Logiq P7GE Healthcare2015131—
+9K141639Voluson S6, Voluson S8GE Healthcare2014151—
+9K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+9K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+9K133533Logiq EGE Healthcare2014149—
+9K133034Logiq F SeriesGE Healthcare2014155—
+9K133431VENUE 50GE Healthcare201360—
+9K131937Voluson I/EGE Healthcare201335—
+9K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+9K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+9K1311184D VIEWGE Healthcare20131—
+9K122387Voluson P6, Voluson P8GE Healthcare2012201—
+9K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+10K262390BoneXpertVisiana20260—
+10K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+10K250914MediAI-BACrescom Co., Ltd.20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K243684BrightHeart View ClassifierBrightheart20251—
+10K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+10K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+10K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—