BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vitrea Advanced Visualization

    DI: 00853866003995 · Model: 7.12.6 · Canon Medical Informatics, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vitrea Advanced Visualization
    Primary DI
    00853866003995
    Version / Model
    7.12.6
    Company Name
    Canon Medical Informatics, Inc.
    Labeler DUNS
    160061651
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-17
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    ea4d126b-1a7f-458a-9612-a6d3b230fa3a

    Device Description

    The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LMD System, Digital Image Communications, Radiological
    LLZ System, Image Processing, Radiological
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00853866003995