510(k) Report

Devices descending from K051139

979 later devices reach Acuson Sequoia Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+5K132274AixplorerSupersonic Imagine2013312—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+5K131158CorviewMarrek, Inc.20130—
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+5K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+5K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+5K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+5K111142Echosoft (TM)Echometrix, LLC20120—
+5K112255AixplorerSupersonic Imagine2012525—
+5K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+5K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+5K110688MylabgoldEsaote2011251
+5K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+5K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+5K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+5K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+5K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+5K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+5K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+5K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+5K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+5K083421MR-Touch OptionGe Medical Systems, LLC20094—
+5K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+6K260748ES-SeriesE-Scopics20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K252105Ligence HeartLigence Uab20250—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K241430EchoMeasureIcardio.Ai20240—
+6K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+6K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+6K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+6K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K212100KosmosEchoNous, Inc.202101
+6K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+6K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+6K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+6K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K191171EchoGo CoreUltromics, Ltd.20193—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+6K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+6K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—