510(k) Report

Devices descending from K051139

979 later devices reach Acuson Sequoia Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+6K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+6K171594AccuroRivanna Medical, LLC20173—
+6K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+6K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+6K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+6K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+6K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+6K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+6K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+6K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+6K150239FibroScanEchosens201525—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+6K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+6K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+6K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+6K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+6K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+6K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+6K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+6K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+6K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+6K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+6K142077MylabgammaEsaote, S.p.A.201453
+6K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+6K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+6K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+6K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+6K140808Q-StationPhilips Ultrasound, Inc.201402
+6K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+6K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+6K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+6K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+6K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+6K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+6K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+6K123806FibroscanEchosens201355—
+6K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+6K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+6K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+6K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+6K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+6K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+6K111582Logiq S8GE Healthcare20113673
+6K110943Logiq E9GE Healthcare20114722
+6K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+6K103649Voluson S6, Voluson S8GE Healthcare2011296—
+6K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+6K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+6K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+6K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+6K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+6K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+6K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K260192DIANAROPCA ApS20260—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+7K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—