BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Siemens Healthineers Ltd.

    Reg #: 3006985147 · FEI: 3006985147 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    65
    Establishment Types
    4
    Classifications
    8

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    Registration Details

    Registration Name
    Siemens Healthineers Ltd.
    Registration Number
    3006985147
    FEI Number
    3006985147
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd, 3rd and 4th Venture Building, Pohang Technopark, 394, Jigok-ro, Nam-gu
    City
    Pohang-si Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K081808

    Owner / Operator

    Firm Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Operator Number
    9002915
    Address
    40 Liberty Boulevard
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    US Agent

    Business Name
    Siemens Medical Solutions USA, Inc.
    Contact Name
    Zhengbin Xu
    Address
    22010 SE 51 Street
    City
    Issaquah
    State
    WA
    ZIP
    98029
    Country
    US
    Email
    [email protected]
    Phone
    425 2418272

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Image Processing, Radiological LLZ
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    ACUSON AcuNav V Diagnostic Ultrasound Catheter AcuNav Crystal Ultrasound Catheter AcuNav Crystal G Ultrasound Catheter ACUSON Origin ICE Diagnostic Ultrasound System ACUSON Origin Diagnostic Ultrasound System ACUSON Sequoia Diagnostic Ultrasound System ACUSON Sequoia Select Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System ACUSON NX2 Diagnostic Ultrasound System SC2000 Diagnostic Ultrasound System SC2000 Workplace ACUSON X800 Diagnostic Ultrasound System Acuson S2000 Diagnostic Ultrasound System Acuson S1000 Diagnostic Ultrasound System Acuson S3000 Diagnostic Ultrasound System ACUSON S2000 ABVS Ultrasound System ACUSON Juniper Diagnostic Ultrasound System ACUSON Juniper Select Diagnostic Ultrasound System ACUSON SC2000 Diagnostic Ultrasound System Elegra Diagnostic Ultrasound System ACUSON P500 Diagnostic Ultrasound System ACUSON S Family (S1000/ S2000 / S3000) Diagnostic Ultrasound System ACUSON Redwood Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System ACUSON Freestyle Diagnostic Ultrasound System ACUSON NX3 Diagnostic Ultrasound System SoundStar eco 10F Diagnostic Ultrasound Catheter SOUNDSTAR™ CRYSTAL Ultrasound Catheter AcuNav 10F Diagnostic Ultrasound Catheter AcuNav 8F Diagnostic Ultrasound Catheter ACUSON G50 Diagnostic Ultrasound System ACUSON G60 Diagnostic Ultrasound System ACUSON S3000 Diagnostic Ultrasound System ACUSON S2000 Diagnostic Ultrasound System ACUSON S1000 Diagnostic Ultrasound System ACUSON Oxana Diagnostic Ultrasound System ACUSON P10 Diagnostic Ultrasound System ACUSON Sequoia Plus Diagnostic Ultrasound System ACUSON Redwood Ultrasound System Acuson P500 Diagnostic Ultrasound System ACUSON P500 Ultrasound System ACUSON P500 ICE Ultrasound System ACUSON P200 Diagnostic Ultrasound System ACUSON X150 Diagnostic Ultrasound System AcuNav Lumos 4D ICE Catheter AcuNav Volume ICE Catheter ACUSON X300 Diagnostic Ultrasound System ACUSON X300PE Diagnostic Ultrasound System Acunav Volume ICE Catheter Acuson SC2000 Diagnostic Ultrasound System ACUSON Antares Diagnostic Ultrasound System ACUSON X700 Diagnostic Ultrasound System ACUSON X600 Diagnostic Ultrasound System ACUSON G20 Diagnostic Ultrasound System ACUSON AcuNav Diagnostic Catheter SoundStar 3D 10F Diagnostic Ultrasound Catheter G60 Diagnostic Ultrasound System ACUSON Maple Diagnostic Ultrasound System ACUSON Maple Select Diagnostic Ultrasound System Acuson AcuNav Diagnostic Catheter ACUSON Adara Diagnostic Ultrasound System SoundStar eco 8F Diagnostic Ultrasound Catheter ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 Elite Diagnostic Ultrasound System X300 Diagnostic Ultrasound System ACUSON AcuNav Volume ICE Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility