BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Radlink DR Tablet Retrofit

    DI: 00864908000100 · Model: DRRETRO · RADLINK, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radlink DR Tablet Retrofit
    Primary DI
    00864908000100
    Version / Model
    DRRETRO
    Company Name
    RADLINK, INC.
    Labeler DUNS
    069190036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-06
    Public Version
    5
    Public Version Date
    2019-04-23
    Public Version Status
    Update
    Public Device Record Key
    982c38ba-693e-41aa-9581-3850be090665

    Device Description

    The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into a mobile digital radiography system.It is a permanently mounted Tablet PC for image acquisition with built-in PACS and DICOM connectivity. Radlink Pro-Imaging Acquisition and Post-Processing Software are featured on the system as well. It comes with a Cesium wireless flat panel detector.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    17904 Computed radiography digital imaging scanner

    Identifiers

    Type ID
    Primary 00864908000100