BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilizat

    Reg #: 3015232217 · FEI: 3015232217 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELEKTA SOLUTIONS AB
    Registration Number
    3015232217
    FEI Number
    3015232217
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hagaplan 4
    City
    STOCKHOLM
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K152321

    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 Inc.
    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
    Accelerator, Linear, Medical IYE

    Proprietary Names

    kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilizat

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device