510(k) Report

Devices descending from K052410

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+7K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+7K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+7K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+7K173569Ultrasound System 1300Bk Medical Aps20181—
+7K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+7K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+7K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+7K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+7K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+7K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+7K170445Logiq S8GE Healthcare2017191
+7K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+7K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+7K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+7K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K160357TrinityKoelis20161—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+7K160524FibroScan 530 CompactEchosens201641—
+7K160182LOGIQ S7 ExpertGE Healthcare2016361
+7K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+7K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+7K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+7K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+7K143452Logiq P9, Logiq P7GE Healthcare2015131—
+7K141639Voluson S6, Voluson S8GE Healthcare2014151—
+7K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+7K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+7K133533Logiq EGE Healthcare2014149—
+7K133034Logiq F SeriesGE Healthcare2014155—
+7K133431VENUE 50GE Healthcare201360—
+7K131937Voluson I/EGE Healthcare201335—
+7K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+7K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+7K1311184D VIEWGE Healthcare20131—
+7K122387Voluson P6, Voluson P8GE Healthcare2012201—
+7K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+8K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+8K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+8K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K242223SuperSonic HepaVuSupersonic Imagine20240—
+8K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+8K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+8K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+8K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+8K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+8K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+8K231764Ultrasound System 1300Bk Medical Aps202301
+8K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+8K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+8K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+8K222441Ultrasound System 2300Bk Medical Aps20221—
+8K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+8K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+8K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+8K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+8K212012Follicle ClarityCycle Clarity20221—
+8K213102ES1 SystemE-Scopics20223—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K212035FibroScan 230Echosens20215—
+8K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—