BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

    Reg #: 1052701 · FEI: 1000222289 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OMEGA MEDICAL IMAGING, LLC
    Registration Number
    1052701
    FEI Number
    1000222289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3400 St. Johns Parkway, Suite 1020
    City
    Sanford
    State
    FL
    ZIP
    32771
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191713

    Owner / Operator

    Firm Name
    OMEGA MEDICAL IMAGING, LLC
    Operator Number
    9000656
    Address
    3400 St. Johns Parkway, Suite 1020, --
    City
    Sanford
    State
    FL
    Postal Code
    32771
    Country
    US
    Correspondent
    Matthew - Anderson

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility