510(k) Report

Devices descending from K934139

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250738YSIO X.preeSiemens Medical Solutions20250—
+11K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+11K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+11K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K243937Accuro 3SRivanna Medical, Inc.20252—
+11K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+11K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+11K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+11K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+11K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+11K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+11K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+11K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+11K241430EchoMeasureIcardio.Ai20240—
+11K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+11K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+11K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+11K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+11K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+11K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+11K232336ES Series V2E-Scopics20232—
+11K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+11K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K223287VelacurSonic Incytes20233—
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+11K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+11K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+11K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+11K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+11K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+11K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+11K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+11K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+11K220243Ultiri Measurement SystemAbbott Medical20220—
+11K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+11K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+11K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+11K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+11K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+11K212100KosmosEchoNous, Inc.202101
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+11K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+11K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+11K200138Versana PremierGe Medical Systems Ultrasound And20202—
+11K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+11K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+11K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+11K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+11K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+11K190078IntraSightVolcano Corporation20192—
+11K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+11K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+11K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+11K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+11K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+11K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+11K172574SyncVision SystemVolcano Corporation201701
+11K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K163505Arietta PrecisionHitachi, Ltd.20170—
+11K170133FFR V2.5Philips Volcano201751
+11K170385CORE M2 Vascular SystemVolcano Corporation20171—
+11K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+11K162583Aloka Lisendo 880Hitachi, Ltd.201602
+11K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+11K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+11K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K131527Logiq S8GE Healthcare2013219—
+11K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691