510(k) Report

Devices descending from K963315

405 later devices reach Vingmed Sound Color Flow Mapping System. System Five through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+10K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+10K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+10K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+10K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+10K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+10K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+10K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+10K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+10K191171EchoGo CoreUltromics, Ltd.20193—
+10K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+10K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+10K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+10K173569Ultrasound System 1300Bk Medical Aps20181—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+10K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+10K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+10K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+10K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+10K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+10K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K251417ReVISION 2Argus Cognitive, Inc.20260—
+11K260192DIANAROPCA ApS20260—
+11K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+11K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+11K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+11K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K250670EchoConfidence (USA)Mycardium AI Limited20250—
+11K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+11K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242359Strain AI (SAI001)Exo, Inc.20240—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+11K232501AI Platform (AIP001)Exo, Inc.20231—
+11K231764Ultrasound System 1300Bk Medical Aps202301
+11K230778EndoCorePraxis Medical, LLC20230—
+11K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+11K222441Ultrasound System 2300Bk Medical Aps20221—
+11K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+11K212376Caas QardiaPie Medical Imaging BV20220—
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+11K213275EchoGo Core (2.0)Ultromics Limited20211—
+11K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+11K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+11K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+11K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+11K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+11K200603AAA ModelPhilips Ultrasound, Inc.20200—
+11K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+11K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+11K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+11K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+11K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+11K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+11K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+11K161999AixplorerSupersonic Imagine201620—
+11K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+11K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+11K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+11K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+11K133277XARIO 100Toshibamedical Systems Corporation20142—
+12K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+12K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+12K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+12K2503303mensio WorkstationPie Medical Imaging BV202501
+12K252007BlineSlideDeep Breathe, Inc.20250—
+12K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+12K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+12K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+12K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+12K234141AISAP Cardio V1.0Aisap20240—
+12K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+12K230209Sonix HealthOntact Health Co., Ltd.20233—
+12K223830Ultrasound System 2300Bk Medical Aps202306
+12K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+12K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+12K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+12K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+12K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+12K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+12K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+12K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—