510(k) Report

Devices descending from K032114

1,003 later devices reach Sequoia 8.0 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+8K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+8K163119NaviSuite SSI EditionMedcom GmbH20171—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+8K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+8K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+8K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+8K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+8K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+8K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+8K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+8K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+8K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+8K150239FibroScanEchosens201525—
+8K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+8K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+8K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+8K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+8K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+8K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+8K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+8K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+8K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+8K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+8K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+8K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+8K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+8K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+8K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+8K142077MylabgammaEsaote, S.p.A.201453
+8K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+8K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+8K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+8K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+8K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+8K140808Q-StationPhilips Ultrasound, Inc.201402
+8K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+8K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+8K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+8K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+8K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+8K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+8K123806FibroscanEchosens201355—
+8K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+8K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+8K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+8K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+8K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+8K111582Logiq S8GE Healthcare20113673
+8K110943Logiq E9GE Healthcare20114722
+8K103649Voluson S6, Voluson S8GE Healthcare2011296—
+8K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+8K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+8K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+9K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—