BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Radmedix AccuVue+

    DI: 00810035220379 · Model: 5 · RADMEDIX, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radmedix AccuVue+
    Primary DI
    00810035220379
    Version / Model
    5
    Company Name
    RADMEDIX, LLC
    Labeler DUNS
    005057263
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-09
    Public Version
    2
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    60168fab-882e-49e0-9528-b38eac80866b

    Device Description

    A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.

    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    57812 Radiology DICOM image processing application software

    Identifiers

    Type ID
    Primary 00810035220379

    Premarket Submissions

    Submission Number Supplement Number
    K201058 000