510(k) Report

Devices descending from K091164

605 later devices reach GE Venue 40, Model 5324338 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+1K091374GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd.2009521—
+2K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+2K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+2K102256GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd.2010511—
+2K102113GE Venue 40 Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd.2010161—
+3K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+3K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+3K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+3K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+3K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K131305Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased ProbeChison Medical Imaging Co., Ltd.20131—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K121867Sonotouch Series Diagnostic Ultrasound SystemsChison Medical Imaging Co., Ltd.20121—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K112371Logiq P3GE Healthcare20110—
+3K112122VENUE 40GE Healthcare2011160—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+4K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+4K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+4K171594AccuroRivanna Medical, LLC20173—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K170870Site~Rite Halcyon Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20170—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+4K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K133533Logiq EGE Healthcare2014149—
+4K133034Logiq F SeriesGE Healthcare2014155—
+4K133431VENUE 50GE Healthcare201360—
+4K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+4K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+4K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+4K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K120741Voluson S6, Voluson S8GE Healthcare2012295—
+5K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+5K243937Accuro 3SRivanna Medical, Inc.20252—
+5K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+5K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+5K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+5K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+5K200708Vivid iqGe Medical Systems Ultrasound And20203—
+5K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K193518KosmosEchoNous, Inc.20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+5K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+5K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+5K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+5K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K163443Interson USB Ultrasound SystemInterson Corporation20173—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+5K162549Lumify Ultrasound SystemPhilips Health Care2016436
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—