510(k) Report

Devices descending from K946179

931 later devices reach Siemens Sonoline 4XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+7K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+7K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+7K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+7K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+7K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+7K161999AixplorerSupersonic Imagine201620—
+7K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+7K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+7K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+7K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+7K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+7K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+7K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+7K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+7K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+7K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+7K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+7K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+7K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+7K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+7K140677MylabssognoEsaote, S.p.A.20140—
+7K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+7K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+7K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+7K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+7K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K132274AixplorerSupersonic Imagine2013312—
+7K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+7K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+7K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+7K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+7K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+7K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+7K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+7K111142Echosoft (TM)Echometrix, LLC20120—
+7K112255AixplorerSupersonic Imagine2012525—
+7K121384MylabsognoEsaote, S.p.A.201211
+7K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+7K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+7K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+7K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+7K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+7K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+7K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+7K110688MylabgoldEsaote2011251
+7K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+7K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+7K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+7K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+7K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+7K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+7K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+7K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+7K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+7K083421MR-Touch OptionGe Medical Systems, LLC20094—
+8K260748ES-SeriesE-Scopics20260—
+8K250955XC11 ICE System, USAYorlabs, Inc.20250—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+8K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K220956Libby Echo:PrioDyad Medical, Inc.20221—
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+8K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+8K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+8K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K193518KosmosEchoNous, Inc.20201—
+8K192372ASCEND Image ViewerAscend Hit20200—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+8K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—