BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MAGNETOM Aera with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

    Reg #: 3002808157 · FEI: 3002808157 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3002808157
    FEI Number
    3002808157
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Allee am Rothelheimpark 2
    City
    ERLANGEN Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191050

    Owner / Operator

    Firm Name
    Siemens Healthineers AG
    Operator Number
    8010024
    Address
    Karlheinz-Kaske-Str. 5, --
    City
    Erlangen
    State
    DE-NOTA
    Postal Code
    91052
    Country
    DE

    US Agent

    Business Name
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Contact Name
    Robert Phillips
    Address
    40 Liberty Boulevard
    City
    MALVERN
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    302 6319702

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    MAGNETOM Aera with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow

    Establishment Types

    Manufacture Medical Device