510(k) Report

Devices descending from K091164

605 later devices reach GE Venue 40, Model 5324338 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+6K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+6K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+6K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+6K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+6K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+6K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+6K160357TrinityKoelis20161—
+6K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+6K160182LOGIQ S7 ExpertGE Healthcare2016361
+6K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+6K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+6K152195Logiq S8GE Healthcare201557—
+6K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+6K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K141675Voluson P6, Voluson P8GE Healthcare201414—
+6K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+6K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+6K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+6K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+6K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+7K250955XC11 ICE System, USAYorlabs, Inc.20250—
+7K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+7K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+7K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+7K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+7K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+7K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K220851VenueGE Medical Systems20223—
+7K220848Venue FitGE Medical Systems202241
+7K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+7K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+7K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+7K211527Exo IrisExo Imaging, Inc.20211—
+7K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+7K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+7K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+7K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+7K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+7K201988T-LiteSonoscanner20201—
+7K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+7K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+7K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+7K192152DC-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—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K190206DC-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—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+7K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+7K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+7K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+7K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—