510(k) Report

Devices descending from K050034

921 later devices reach Sonoline Antares Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K120282CardnavPaieon, Inc.20120—
+4K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+4K111142Echosoft (TM)Echometrix, LLC20120—
+4K112255AixplorerSupersonic Imagine2012525—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+4K110688MylabgoldEsaote2011251
+4K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+4K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+4K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+4K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K260748ES-SeriesE-Scopics20260—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+5K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+5K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+5K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K181637DC-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—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+5K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+5K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+5K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+5K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+5K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+5K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+5K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+5K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+5K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K150239FibroScanEchosens201525—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+5K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+5K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—