BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Leksell Gamma Knife - Espirit, Leksell Gamma Knife Icon, Leksell Gamma Knife Perfexion

    Reg #: 9612186 · FEI: 3002806883 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Elekta Instrument AB
    Registration Number
    9612186
    FEI Number
    3002806883
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hagaplan 4
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K250391

    Owner / Operator

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

    US Agent

    Business Name
    Elekta
    Contact Name
    Thomas Valentine
    Address
    400 Perimeter Center Terrace, Suite 50
    City
    ATL
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    404 7972537

    Products

    Device Name Product Code
    System, Radiation Therapy, Radionuclide IWB

    Proprietary Names

    Leksell Gamma Knife - Espirit, Leksell Gamma Knife Icon, Leksell Gamma Knife Perfexion

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)