510(k) Report

Devices descending from K991611

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+10K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+10K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+10K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+10K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+10K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242359Strain AI (SAI001)Exo, Inc.20240—
+10K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K2301796440 MyLabX90Esaote, S.p.A.202341
+10K232501AI Platform (AIP001)Exo, Inc.20231—
+10K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+10K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+10K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+10K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+10K213275EchoGo Core (2.0)Ultromics Limited20211—
+10K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211527Exo IrisExo Imaging, Inc.20211—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+10K200603AAA ModelPhilips Ultrasound, Inc.20200—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+10K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+10K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+10K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+10K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+10K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+10K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+10K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+10K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+10K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+10K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+10K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+10K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+10K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+10K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+10K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+10K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+10K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+10K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+10K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+10K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+10K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+10K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+10K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+10K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+10K1808835D ViewerSamsung Medison Co., Ltd.20180—
+10K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+10K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+10K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+10K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+10K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+10K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+10K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+10K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+10K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+10K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+10K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+10K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+10K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+10K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+10K1725133D EchoJointvue, LLC20171—
+10K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+10K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+10K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+10K170841BiopSee, Mobile USMedcom GmbH20170—
+10K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+10K163505Arietta PrecisionHitachi, Ltd.20170—
+10K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+10K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+10K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K162583Aloka Lisendo 880Hitachi, Ltd.201602
+10K163020Xperius Ultrasound SystemPhilips Health Care201611
+10K161960bk2300Bk Medical Aps20165—
+10K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+10K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—