BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AcuityDR 1013 G4

    Reg #: 3009134655 · FEI: 3009134655 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RadmediX, LLC
    Registration Number
    3009134655
    FEI Number
    3009134655
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2510 Lance Dr.
    City
    Dayton
    State
    OH
    ZIP
    45409
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231709

    Owner / Operator

    Firm Name
    RadmediX, LLC
    Operator Number
    10036858
    Address
    2510 Lance Dr.
    City
    Dayton
    State
    OH
    Postal Code
    45409
    Country
    US
    Correspondent
    Gabriel Issa

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, Image Processing, Radiological LLZ

    Proprietary Names

    AcuityDR 1013 G4 AcuityDR 1417 G4 AcuityDR 1717G4

    Establishment Types

    Manufacture Medical Device