510(k) Report

Devices descending from K033196

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011100—
+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
+4K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+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
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K083597Sonowand InviteSonowand AS20093—
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+4K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+4K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+4K070515A-View Basic and PlusCordatec N.V.20071—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+4K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+5K260748ES-SeriesE-Scopics20260—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+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
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+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—
+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
+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
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K170338A-ViewStroke2prevent B.V.20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K163690DC-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—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+5K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+5K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+5K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+5K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+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
+5K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K150239FibroScanEchosens201525—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+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—
+5K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—