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
+7K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+7K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+7K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+7K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+7K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+7K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+7K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+7K140677MylabssognoEsaote, S.p.A.20140—
+7K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+7K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+7K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+7K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+7K132274AixplorerSupersonic Imagine2013312—
+7K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+7K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+7K111142Echosoft (TM)Echometrix, LLC20120—
+7K112255AixplorerSupersonic Imagine2012525—
+7K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+7K121384MylabsognoEsaote, S.p.A.201211
+7K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+7K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+7K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+7K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+7K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+7K110688MylabgoldEsaote2011251
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+7K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+7K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+7K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+7K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+7K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+7K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+7K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+7K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+7K083421MR-Touch OptionGe Medical Systems, LLC20094—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+7K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+8K260748ES-SeriesE-Scopics20260—
+8K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+8K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K252105Ligence HeartLigence Uab20250—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K250120GECHONarnar, LLC20250—
+8K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K243937Accuro 3SRivanna Medical, Inc.20252—
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+8K241430EchoMeasureIcardio.Ai20240—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212100KosmosEchoNous, Inc.202101
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+8K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+8K201768Voluson E10GE Healthcare20204—
+8K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+8K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+8K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+8K181637DC-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—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—