BEUDAMED
    FDA Registration Active 🇺🇸 United States

    xCAT

    Reg #: 3004198450 · FEI: 3004198450 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Xoran Technologies, LLC
    Registration Number
    3004198450
    FEI Number
    3004198450
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5210 South State Road
    City
    Ann Arbor
    State
    MI
    ZIP
    48108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061834

    Owner / Operator

    Firm Name
    Xoran Technologies LLC
    Operator Number
    10028111
    Address
    5210 South State Street
    City
    Ann Arbor
    State
    MI
    Postal Code
    48108
    Country
    US

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    xCAT xCATIQ xCAT XL

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device