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
+7K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+7K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+7K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+7K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K171594AccuroRivanna Medical, LLC20173—
+7K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+7K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+7K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+7K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+7K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+7K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+7K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+7K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+7K152922ViziShot FLEXSpiration, Inc.20166—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+7K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+7K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+7K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+7K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+7K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+7K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+7K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+7K130779Lvivo EF SystemDiacardio, Ltd.201324—
+7K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+7K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+7K120282CardnavPaieon, Inc.20120—
+7K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+7K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+7K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+7K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+7K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+7K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+7K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+7K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+7K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+7K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+7K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+7K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+7K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+7K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+7K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+7K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+7K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+8K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+8K250145Biopsy Port AdapterEndosound, Inc.20250—
+8K243937Accuro 3SRivanna Medical, Inc.20252—
+8K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+8K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+8K231267ClearTipFinemedix Co., Ltd.20231—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+8K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+8K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+8K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+8K193518KosmosEchoNous, Inc.20201—
+8K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+8K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+8K190669EndoticsEra Endoscopy S.R.L.20200—
+8K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+8K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+8K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+8K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+8K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+8K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+8K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+8K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+8K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+8K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+8K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+8K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+8K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301