BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMAGING ENGINEERING, LLC

    Reg #: 3015437189 · FEI: 3015437189 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    IMAGING ENGINEERING, LLC
    Registration Number
    3015437189
    FEI Number
    3015437189
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4424 NW 13th Street, Suite B-12
    City
    Gainesville
    State
    FL
    ZIP
    32609
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200396

    Owner / Operator

    Firm Name
    Imaging Engineering, LLC
    Operator Number
    10060138
    Address
    4424 NW 13th Street, Suite B-12
    City
    Gainesville
    State
    FL
    Postal Code
    32609
    Country
    US
    Correspondent
    george Jachode

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    Solid State Fluoroscopic X-Ray Imager QHY
    C-Arm Fluoroscopic X-Ray System RCC

    Proprietary Names

    Insight Enhanced Insight Enhanced DRF Insight Agile DRF

    Establishment Types

    Manufacture Medical Device