510(k) Report

Devices descending from K935595

1,088 later devices reach Acuson Model 3001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+9K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K181637DC-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—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+9K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+9K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+9K1808835D ViewerSamsung Medison Co., Ltd.20180—
+9K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+9K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+9K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+9K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+9K173555Logiq E10GE Healthcare2017382
+9K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+9K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+9K1725133D EchoJointvue, LLC20171—
+9K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K171164U-Lite EXPSonoscanner20172—
+9K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+9K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+9K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+9K161960bk2300Bk Medical Aps20165—
+9K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+9K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+9K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+9K160162Voluson P6, Voluson P8GE Healthcare201613—
+9K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+9K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+9K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+9K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+9K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+9K150239FibroScanEchosens201525—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+9K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K140808Q-StationPhilips Ultrasound, Inc.201402
+9K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+9K133277XARIO 100Toshibamedical Systems Corporation20142—
+9K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+9K123806FibroscanEchosens201355—
+9K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K252332FolliscanMim Fertility20260—
+10K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K252105Ligence HeartLigence Uab20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+10K241430EchoMeasureIcardio.Ai20240—
+10K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+10K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+10K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—