BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DynaCAD Lung Server; Veolity LungCAD; Visia Lung

    Reg #: 3010601176 · FEI: 3010601176 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEVIS MEDICAL SOLUTIONS AG
    Registration Number
    3010601176
    FEI Number
    3010601176
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Caroline-Herschel-Str. 1
    City
    Bremen
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K043617

    Owner / Operator

    Firm Name
    Varex Imaging Corporation
    Operator Number
    10053550
    Address
    1678 South Pioneer Road
    City
    Salt Lake City
    State
    UT
    Postal Code
    84104
    Country
    US

    US Agent

    Business Name
    Varex Imaging Corporation
    Contact Name
    Victor Garcia
    Address
    1678 South Pioneer Road
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US
    Email
    [email protected]
    Phone
    801 9785399

    Products

    Device Name Product Code
    Lung Computed Tomography System, Computer-Aided Detection OEB

    Proprietary Names

    DynaCAD Lung Server; Veolity LungCAD; Visia Lung

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198