510(k) Report

Devices descending from K945072

1,034 later devices reach Siemens Q4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250670EchoConfidence (USA)Mycardium AI Limited20250—
+10K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+10K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+10K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+10K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+10K241430EchoMeasureIcardio.Ai20240—
+10K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+10K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+10K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+10K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+10K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+10K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+10K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+10K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+10K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+10K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+10K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+10K222406Clarius AIClarius Mobile Health Corp.20233—
+10K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+10K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+10K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+10K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+10K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K2116563D Echo v1.1Jointvue, LLC20210—
+10K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+10K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+10K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+10K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+10K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+10K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+10K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+10K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+10K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+10K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+10K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+10K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+10K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+10K191171EchoGo CoreUltromics, Ltd.20193—
+10K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+10K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+10K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+10K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+10K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+10K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+10K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+10K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+10K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+10K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+10K173555Logiq E10GE Healthcare2017382
+10K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+10K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+10K160162Voluson P6, Voluson P8GE Healthcare201613—
+10K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+10K160524FibroScan 530 CompactEchosens201641—
+10K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+10K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+10K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+10K133277XARIO 100Toshibamedical Systems Corporation20142—
+11K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K251417ReVISION 2Argus Cognitive, Inc.20260—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K260192DIANAROPCA ApS20260—
+11K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+11K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—