BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Xoft Axxent Electronic Brachytherapy System

    Reg #: 3032638959 · FEI: 3032638959 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Elekta Inc.
    Registration Number
    3032638959
    FEI Number
    3032638959
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Nicholson Ln
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050843

    Owner / Operator

    Firm Name
    ELEKTA AB
    Operator Number
    8030893
    Address
    Hagaplan 4
    City
    Stockholm
    State
    SE-AB
    Postal Code
    SE11368
    Country
    SE

    Products

    Device Name Product Code
    System, Therapeutic, X-Ray JAD

    Proprietary Names

    Xoft Axxent Electronic Brachytherapy System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)