BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    TOMTEC Imaging Systems GMBH

    Reg #: 8043836 · FEI: 1000185293 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TOMTEC Imaging Systems GMBH
    Registration Number
    8043836
    FEI Number
    1000185293
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Freisinger Strasse 9
    City
    UNTERSCHLEISSHEIM Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K241659

    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

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Ultrasound Workspace TomTec-Arena TOMTEC-ARENA Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5 Image-Arena and Image-Arena Applications

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility