510(k) Report

Devices descending from K991611

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+7K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+7K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+7K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+7K132171AixplorerSupersonic Imagine201364—
+7K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+7K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+7K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+7K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+7K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+7K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+7K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+7K121329AixplorerSupersonic Imagine2012405—
+7K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+7K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+7K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+7K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+7K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+7K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+7K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+7K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+7K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+7K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+7K102041AixplorerSupersonic Imagine2010527—
+7K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+7K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+7K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+7K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+7K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+7K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+7K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+7K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+8K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+8K253452Accuro 3SRivanna Medical, Inc.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K254021Accuro XVRivanna Medical, Inc.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+8K250955XC11 ICE System, USAYorlabs, Inc.20250—
+8K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+8K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+8K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+8K220956Libby Echo:PrioDyad Medical, Inc.20221—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212100KosmosEchoNous, Inc.202101
+8K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+8K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+8K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+8K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K192372ASCEND Image ViewerAscend Hit20200—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+8K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+8K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762