BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    AGFA HEALTHCARE N.V.

    Reg #: 9616389 · FEI: 3009471886 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    AGFA HEALTHCARE N.V.
    Registration Number
    9616389
    FEI Number
    3009471886
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SEPTESTRAAT 27
    City
    MORTSEL Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K143397

    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
    Template HWT

    Proprietary Names

    Enterprise Imaging XERO Viewer Enterprise Imaging Desktops IMPAX Mammography Workstation MA3000 Impax for Breast Imaging Impax Orthopaedic Workstation OT 3000 Impax Volume Viewing IMPAX IMPAX Volume Viewing 4 IMPAX Orthopaedic Workstation Ortho Tool Kit IMPAX Diagnostic Workstation IMPAX Quality Control Workstation IMPAX Clinical Workstation IMPAX Workstation IMPAX PET & SPECT Viewing IMPAX Registration & Fusion Impax Volume Viewing 3 Enterprise Imaging XERO Viewer 3D Enterprise Imaging XERO Viewer 8.1 XERO Viewer Enterprise Imaging

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility