BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    AlignRT

    Reg #: 3004832819 · FEI: 3004832819 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    VISION RT LIMITED
    Registration Number
    3004832819
    FEI Number
    3004832819
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dove House, Arcadia Avenue
    City
    LONDON London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K212583

    Owner / Operator

    Firm Name
    VISION RT LIMITED
    Operator Number
    9063759
    Address
    Dove House, Arcadia Avenue
    City
    LONDON
    State
    London, City of
    Postal Code
    N3 2JU
    Country
    GB
    Correspondent
    Amy Mansfield

    US Agent

    Business Name
    Vision RT
    Contact Name
    Ben Waghorn
    Address
    1710 Broadwell Oaks Dr
    City
    Alpharetta
    State
    GA
    ZIP
    30004
    Country
    US
    Email
    [email protected]
    Phone
    770 8230790

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    AlignRT Touchless4D AlignRT Offline AlignRT Plus AlignRT Advance AlignRT InBore OSMS SimRT

    Establishment Types

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