510(k) Report

Devices descending from K052410

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+5K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+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
+5K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+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
+5K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+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—
+5K150239FibroScanEchosens201525—
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+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—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+5K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+5K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+5K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+5K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+5K123806FibroscanEchosens201355—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+5K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+5K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+5K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+5K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+5K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+5K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K260192DIANAROPCA ApS20260—
+6K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+6K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+6K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+6K242359Strain AI (SAI001)Exo, Inc.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+6K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+6K232501AI Platform (AIP001)Exo, Inc.20231—