BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AGFA HEALTHCARE INC.

    Reg #: 9680497 · FEI: 3008794078 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AGFA HEALTHCARE INC.
    Registration Number
    9680497
    FEI Number
    3008794078
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    375 Hagey Boulevard
    City
    WATERLOO Ontario
    Country
    CA

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility