BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RadmediX, LLC

    Reg #: 3009134655 · FEI: 3009134655 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    RadmediX, LLC
    Registration Number
    3009134655
    FEI Number
    3009134655
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2510 Lance Dr.
    City
    Dayton
    State
    OH
    ZIP
    45409
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193360

    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, X-Ray, Stationary KPR
    System, Image Processing, Radiological LLZ
    System, X-Ray, Mobile IZL
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    AcuityFDR AcuitySDR+ AcuityCDR AcuityFDR+ AcuitySDR AcuityDRe 1417w AcuityDRe 1717w AcuityDRe 1717t AccuVue AcuityPDR AcuityPDR+ AcuityDX+ AcuityUDR AccuPACS Local AcuityDR 1417 G4 AcuityDR 1013 G4 AcuityDR 1717G4

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device