510(k) Report

Devices descending from K063085

838 later devices reach Modification to Acuson Sequoia Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+4K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+4K123806FibroscanEchosens201355—
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+4K111582Logiq S8GE Healthcare20113673
+4K110943Logiq E9GE Healthcare20114722
+4K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+4K103649Voluson S6, Voluson S8GE Healthcare2011296—
+4K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+4K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+4K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+4K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+4K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+4K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+4K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+5K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+5K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+5K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+5K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+5K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+5K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+5K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+5K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+5K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+5K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+5K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181637DC-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—
+5K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+5K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+5K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+5K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+5K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+5K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+5K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+5K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K1725133D EchoJointvue, LLC20171—
+5K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K163505Arietta PrecisionHitachi, Ltd.20170—
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+5K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K162583Aloka Lisendo 880Hitachi, Ltd.201602
+5K163020Xperius Ultrasound SystemPhilips Health Care201611
+5K161960bk2300Bk Medical Aps20165—