510(k) Report

Devices descending from K063803

801 later devices reach Acuson Antares Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+1K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+1K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+2K142100AixplorerSupersonic Imagine201463—
+2K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+2K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+2K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+2K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+2K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+2K132171AixplorerSupersonic Imagine201364—
+2K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+2K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+2K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+2K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+2K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+2K121329AixplorerSupersonic Imagine2012405—
+2K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+2K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+2K102041AixplorerSupersonic Imagine2010527—
+2K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+2K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+2K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+2K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+2K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+2K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+3K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K161999AixplorerSupersonic Imagine201620—
+3K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+3K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+3K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+3K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+3K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+3K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+3K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+3K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+3K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+3K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+3K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+3K132274AixplorerSupersonic Imagine2013312—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+3K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+3K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+3K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+3K111142Echosoft (TM)Echometrix, LLC20120—
+3K112255AixplorerSupersonic Imagine2012525—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+3K110688MylabgoldEsaote2011251
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K260748ES-SeriesE-Scopics20260—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—