BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PowerDR PACS

    Reg #: 1125622 · FEI: 3002952981 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    RADIOLOGY INFORMATION SYSTEMS, INC.
    Registration Number
    1125622
    FEI Number
    3002952981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43676 TRADE CENTER PLACE, SUITE 100
    City
    DULLES
    State
    VA
    ZIP
    20166
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191504

    Owner / Operator

    Firm Name
    RADIOLOGY INFORMATION SYSTEMS, INC.
    Operator Number
    9029503
    Address
    43676 TRADE CENTER PLACE, SUITE 100
    City
    Dulles
    State
    VA
    Postal Code
    20166
    Country
    US
    Correspondent
    Chen-Tai - MA

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    PowerDR PACS

    Establishment Types

    Manufacture Medical Device