510(k) Report

Devices descending from K052410

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+3K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+3K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+3K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+3K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+4K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+4K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K220956Libby Echo:PrioDyad Medical, Inc.20221—
+4K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+4K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+4K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+4K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+4K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+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—
+4K193518KosmosEchoNous, Inc.20201—
+4K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+4K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+4K192372ASCEND Image ViewerAscend Hit20200—
+4K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+4K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+4K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K181574UscanEchoNous, Inc.20180—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+4K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+4K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+4K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+4K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+4K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+4K163690DC-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—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K161999AixplorerSupersonic Imagine201620—
+4K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+4K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+4K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+4K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+4K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+4K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+4K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+4K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+4K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+4K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+4K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+4K132274AixplorerSupersonic Imagine2013312—
+4K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+4K131158CorviewMarrek, Inc.20130—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+4K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+4K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+4K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+4K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K111142Echosoft (TM)Echometrix, LLC20120—
+4K112255AixplorerSupersonic Imagine2012525—
+4K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+4K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—