510(k) Report

Devices descending from K061129

430 later devices reach GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+1K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+1K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+1K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+1K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+2K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+2K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+2K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+2K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+2K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+2K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+2K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+2K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+2K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+2K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+2K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+2K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+2K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+2K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+2K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+3K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+3K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+3K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+3K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+3K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+3K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+3K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+3K133533Logiq EGE Healthcare2014149—
+3K133431VENUE 50GE Healthcare201360—
+3K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+3K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+3K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+3K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+3K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+3K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+3K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+3K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+3K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+3K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+4K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+4K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+4K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+4K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+4K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+4K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+4K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+4K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+4K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+4K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+4K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+4K143601U-LiteSonoscanner Sarl20153—
+4K143452Logiq P9, Logiq P7GE Healthcare2015131—
+4K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+4K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+4K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+4K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+5K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—