BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5

    Reg #: 8043836 · FEI: 1000185293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TOMTEC Imaging Systems GMBH
    Registration Number
    8043836
    FEI Number
    1000185293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Freisinger Strasse 9
    City
    UNTERSCHLEISSHEIM Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K110667

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Ondrea Bermudez
    Address
    3721 Valley Centre Dr
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    443 3200028

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5 Image-Arena and Image-Arena Applications

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility