BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Enterprise Imaging

    Reg #: 3009238185 · FEI: 3009238185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Agfa HealthCare GmbH
    Registration Number
    3009238185
    FEI Number
    3009238185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Diefenbachgasse 35
    City
    Vienna Wien
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K170434

    Owner / Operator

    Firm Name
    AGFA HEALTHCARE N.V.
    Operator Number
    9011611
    Address
    375 Hagey Blvd
    City
    Waterloo
    State
    Ontario
    Postal Code
    N2L 6R5
    Country
    CA

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Enterprise Imaging Enterprise Imaging XERO Viewer 8.1 XERO Viewer

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility