BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    IMPAX PET & SPECT Viewing

    Reg #: 9616389 · FEI: 3009471886 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    AGFA HEALTHCARE N.V.
    Registration Number
    9616389
    FEI Number
    3009471886
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SEPTESTRAAT 27
    City
    MORTSEL Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K080013

    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

    IMPAX PET & SPECT Viewing IMPAX Registration & Fusion

    Establishment Types

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