BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS

    Reg #: 3004977335 · FEI: 3004977335 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Siemens Healthineers AG
    Registration Number
    3004977335
    FEI Number
    3004977335
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SIEMENSSTRASSE 1 -OR-, Rittigfeld 1
    City
    FORCHHEIM Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K112112

    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 2359839

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device