510(k) Report

Devices descending from K033196

990 later devices reach Sonoline Antares with Clarify VE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+1K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+1K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+2K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+2K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+2K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+2K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+2K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+2K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+3K142100AixplorerSupersonic Imagine201463—
+3K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+3K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+3K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+3K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+3K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+3K132171AixplorerSupersonic Imagine201364—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+3K121329AixplorerSupersonic Imagine2012405—
+3K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K102041AixplorerSupersonic Imagine2010527—
+3K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+3K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+3K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+3K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+3K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+3K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008278—
+3K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc.20072795
+3K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+3K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2007427—
+3K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+3K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+3K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+3K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+4K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+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—
+4K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+4K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+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
+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—
+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—
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+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—
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+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—
+4K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+4K132274AixplorerSupersonic Imagine2013312—
+4K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+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—
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K111142Echosoft (TM)Echometrix, LLC20120—
+4K112255AixplorerSupersonic Imagine2012525—
+4K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K121384MylabsognoEsaote, S.p.A.201211