BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FLUSION-9001Fluoroscopic C-arm Mobile X-ray System with model(s) Blazar, Gravity, Quasar

    Reg #: 3012624817 · FEI: 3012624817 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ASPEN IMAGING HEALTHCARE, INC
    Registration Number
    3012624817
    FEI Number
    3012624817
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    801 north Jupiter rd, 200
    City
    Plano
    State
    TX
    ZIP
    75074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200022

    Owner / Operator

    Firm Name
    ASPEN IMAGING HEALTHCARE, INC
    Operator Number
    10051160
    Address
    801 Jupiter Rd, Suite 200, 200
    City
    Plano
    State
    TX
    Postal Code
    75074
    Country
    US

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO

    Proprietary Names

    FLUSION-9001Fluoroscopic C-arm Mobile X-ray System with model(s) Blazar, Gravity, Quasar

    Establishment Types

    Manufacture Medical Device