BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AIRO Computed Tomography (CT) X-ray System

    Reg #: 3010151377 · FEI: 3010151377 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MOBIUS IMAGING, LLC
    Registration Number
    3010151377
    FEI Number
    3010151377
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Shaker Road, Suite F100
    City
    Shirley
    State
    MA
    ZIP
    01464
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180393

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

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

    Proprietary Names

    AIRO Computed Tomography (CT) X-ray System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility