510(k) Report

Devices descending from K001400

982 later devices reach Elegra Millennium Enhanced Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+8K170521Trinity/3D Prostate SuiteKoelis20170—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K170445Logiq S8GE Healthcare2017191
+8K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+8K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+8K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+8K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+8K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+8K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K160357TrinityKoelis20161—
+8K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+8K160420SpeqTSignostics Limited20161—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc.20150—
+8K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+8K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+8K141639Voluson S6, Voluson S8GE Healthcare2014151—
+8K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+8K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+8K133034Logiq F SeriesGE Healthcare2014155—
+8K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+8K131937Voluson I/EGE Healthcare201335—
+8K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+8K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+8K1311184D VIEWGE Healthcare20131—
+8K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+8K122387Voluson P6, Voluson P8GE Healthcare2012201—
+8K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+9K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+9K251417ReVISION 2Argus Cognitive, Inc.20260—
+9K260192DIANAROPCA ApS20260—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+9K251673X9 Ultrasound SystemX9, Inc.20250—
+9K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+9K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K242359Strain AI (SAI001)Exo, Inc.20240—
+9K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+9K232285U-Lite PROSonoscanner Sarl20240—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232501AI Platform (AIP001)Exo, Inc.20231—
+9K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K223287VelacurSonic Incytes20233—
+9K223830Ultrasound System 2300Bk Medical Aps202306
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+9K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220851VenueGE Medical Systems20223—
+9K220848Venue FitGE Medical Systems202241
+9K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+9K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+9K212376Caas QardiaPie Medical Imaging BV20220—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+9K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+9K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+9K212012Follicle ClarityCycle Clarity20221—