510(k) Report

Devices descending from K934139

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+12K253452Accuro 3SRivanna Medical, Inc.20260—
+12K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K260589ES-SeriesE-Scopics20260—
+12K254021Accuro XVRivanna Medical, Inc.20260—
+12K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+12K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+12K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+12K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+12K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+12K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+12K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+12K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+12K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+12K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+12K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+12K232459VelacurSonic Incytes20232—
+12K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K220851VenueGE Medical Systems20223—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+12K211488Logiq E10GE Healthcare202111—
+12K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+12K203719IntraSight MobileVolcano Corporation202101
+12K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+12K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+12K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+12K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+12K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+12K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+12K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+12K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+12K160357TrinityKoelis20161—
+12K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+12K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+12K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+12K143452Logiq P9, Logiq P7GE Healthcare2015131—
+12K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+12K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+12K141639Voluson S6, Voluson S8GE Healthcare2014151—
+12K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+12K133533Logiq EGE Healthcare2014149—
+12K133034Logiq F SeriesGE Healthcare2014155—
+12K133277XARIO 100Toshibamedical Systems Corporation20142—
+12K133431VENUE 50GE Healthcare201360—
+12K131937Voluson I/EGE Healthcare201335—
+12K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+12K1311184D VIEWGE Healthcare20131—
+12K122387Voluson P6, Voluson P8GE Healthcare2012201—
+12K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+13K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+13K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+13K251827Azurion R3.1Philips Medical Systems B.V.20251—
+13K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+13K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+13K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+13K233977VelacurSonic Incytes20241—
+13K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+13K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+13K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+13K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+13K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+13K220848Venue FitGE Medical Systems202241
+13K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+13K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+13K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+13K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+13K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+13K183456Aloka Arietta 850Hitachi Healthcare Americas201923