510(k) Report

Devices descending from K041319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+6K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+6K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+6K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+6K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+6K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+6K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+6K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+6K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+6K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+6K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+6K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+6K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+6K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+6K140677MylabssognoEsaote, S.p.A.20140—
+6K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+6K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+6K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+6K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+6K132274AixplorerSupersonic Imagine2013312—
+6K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+6K131158CorviewMarrek, Inc.20130—
+6K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+6K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+6K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+6K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+6K111142Echosoft (TM)Echometrix, LLC20120—
+6K112255AixplorerSupersonic Imagine2012525—
+6K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+6K121384MylabsognoEsaote, S.p.A.201211
+6K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+6K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+6K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+6K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+6K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+6K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+6K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+6K110688MylabgoldEsaote2011251
+6K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+6K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+6K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+6K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+6K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+6K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+6K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+6K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+6K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+6K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+6K083421MR-Touch OptionGe Medical Systems, LLC20094—
+6K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+6K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+7K260748ES-SeriesE-Scopics20260—
+7K250955XC11 ICE System, USAYorlabs, Inc.20250—
+7K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K252105Ligence HeartLigence Uab20250—
+7K250120GECHONarnar, LLC20250—
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K241430EchoMeasureIcardio.Ai20240—
+7K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+7K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+7K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+7K222406Clarius AIClarius Mobile Health Corp.20233—
+7K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+7K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K212100KosmosEchoNous, Inc.202101
+7K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+7K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+7K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+7K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+7K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+7K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+7K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—