510(k) Report

Devices descending from K934139

1,289 later devices reach Tomtec Echo-View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+8K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+8K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+8K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+8K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K212012Follicle ClarityCycle Clarity20221—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+8K213275EchoGo Core (2.0)Ultromics Limited20211—
+8K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+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—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+8K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+8K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+8K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K200603AAA ModelPhilips Ultrasound, Inc.20200—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K2013523D Auto LAAPhilips Health Care20200—
+8K193277SOMATOM On.site and On.sceneSiemens Medical Solutions USA, Inc.20201—
+8K200356Medo AriaMedo.Ai20203—
+8K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+8K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+8K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+8K192152DC-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—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+8K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K182639MOBILETT Elara MaxSiemens Medi Cal Solutions, Inc.20190—
+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—
+8K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+8K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+8K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+8K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+8K181966SmartPerfusionPhilips Medical Systems Nederlands B.V.201801
+8K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.20181359
+8K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+8K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+8K181574UscanEchoNous, Inc.20180—
+8K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+8K181279Ysio MaxSiemens Medi Cal Solutions, Inc.20183—
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K173569Ultrasound System 1300Bk Medical Aps20181—
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K171194AS-10, Cxdi-401RFCanon, Inc.20173—
+8K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K163286ARTIS phenoSiemens Medical Solution USA, Inc.20172314
+8K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K160455AneurysmFlowPhilips Medical Systems Nederland B.V.201601
+8K161019Uroview FDPausch Medical GmbH201621
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+8K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—