510(k) Report

Devices descending from K991611

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+8K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+8K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+8K161999AixplorerSupersonic Imagine201620—
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+8K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+8K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+8K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+8K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+8K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+8K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+8K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+8K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+8K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+8K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+8K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+8K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+8K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+8K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+8K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+8K140677MylabssognoEsaote, S.p.A.20140—
+8K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+8K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+8K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+8K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+8K132274AixplorerSupersonic Imagine2013312—
+8K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+8K131158CorviewMarrek, Inc.20130—
+8K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+8K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+8K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+8K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+8K111142Echosoft (TM)Echometrix, LLC20120—
+8K112255AixplorerSupersonic Imagine2012525—
+8K121384MylabsognoEsaote, S.p.A.201211
+8K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+8K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+8K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+8K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+8K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+8K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+8K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+8K110688MylabgoldEsaote2011251
+8K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+8K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+8K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+8K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+8K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+8K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+8K083421MR-Touch OptionGe Medical Systems, LLC20094—
+9K260748ES-SeriesE-Scopics20260—
+9K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+9K252105Ligence HeartLigence Uab20250—
+9K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K250670EchoConfidence (USA)Mycardium AI Limited20250—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+9K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+9K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+9K241430EchoMeasureIcardio.Ai20240—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+9K230778EndoCorePraxis Medical, LLC20230—
+9K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+9K222406Clarius AIClarius Mobile Health Corp.20233—
+9K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+9K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+9K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+9K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+9K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+9K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+9K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+9K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+9K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+9K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185