BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system

    Reg #: 1052701 · FEI: 1000222289 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    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
    K070834

    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
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB

    Proprietary Names

    ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device