510(k) Report

Devices descending from K991611

1,015 later devices reach GE Logiq 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+11K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+11K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+11K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+11K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+11K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+11K170445Logiq S8GE Healthcare2017191
+11K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+11K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+11K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+11K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+11K160357TrinityKoelis20161—
+11K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+11K160524FibroScan 530 CompactEchosens201641—
+11K160182LOGIQ S7 ExpertGE Healthcare2016361
+11K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+11K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+11K143452Logiq P9, Logiq P7GE Healthcare2015131—
+11K141639Voluson S6, Voluson S8GE Healthcare2014151—
+11K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+11K133533Logiq EGE Healthcare2014149—
+11K133034Logiq F SeriesGE Healthcare2014155—
+11K133431VENUE 50GE Healthcare201360—
+11K131937Voluson I/EGE Healthcare201335—
+11K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+11K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+11K1311184D VIEWGE Healthcare20131—
+11K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+11K122387Voluson P6, Voluson P8GE Healthcare2012201—
+11K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+12K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+12K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+12K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+12K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+12K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+12K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+12K243684BrightHeart View ClassifierBrightheart20251—
+12K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+12K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+12K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+12K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+12K240645Sonix HealthOntact Health Co., Ltd.20240—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+12K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+12K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+12K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+12K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+12K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+12K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+12K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+12K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+12K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K212012Follicle ClarityCycle Clarity20221—
+12K213102ES1 SystemE-Scopics20223—
+12K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+12K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+12K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+12K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+12K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+12K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+12K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+12K212035FibroScan 230Echosens20215—
+12K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+12K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+12K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+12K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+12K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+12K201768Voluson E10GE Healthcare20204—
+12K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+12K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+12K2013523D Auto LAAPhilips Health Care20200—
+12K201597Liver Incytes, Model 1005Sonic Incytes20204—
+12K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+12K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+12K200356Medo AriaMedo.Ai20203—
+12K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+12K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+12K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+12K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+12K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+12K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+12K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+12K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+12K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—