510(k) Report

Devices descending from K970901

1,017 later devices reach GE Logiq 500 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+11K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+11K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+11K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+11K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+11K152195Logiq S8GE Healthcare201557—
+11K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+11K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+11K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+11K150949FibroScanEchosens201542—
+11K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+11K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+11K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+11K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+11K131527Logiq S8GE Healthcare2013219—
+11K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+11K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+12K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+12K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+12K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+12K2503303mensio WorkstationPie Medical Imaging BV202501
+12K252007BlineSlideDeep Breathe, Inc.20250—
+12K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+12K250120GECHONarnar, LLC20250—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+12K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+12K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+12K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+12K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+12K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+12K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+12K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+12K234141AISAP Cardio V1.0Aisap20240—
+12K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+12K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+12K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+12K230209Sonix HealthOntact Health Co., Ltd.20233—
+12K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+12K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+12K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+12K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+12K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+12K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+12K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+12K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+12K2116563D Echo v1.1Jointvue, LLC20210—
+12K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+12K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+12K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+12K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+12K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+12K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+12K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+12K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+12K200655FibroScan® 630Echosens20200—
+12K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+12K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+12K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+12K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+12K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+12K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+12K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+12K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+12K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+12K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+12K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+12K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+12K192152DC-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—
+12K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+12K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+12K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+12K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+12K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+12K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+12K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+12K190206DC-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—
+12K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+12K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+12K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+12K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+12K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+12K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—