BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vitrea

    DI: 00853866003247 · Model: 6.9.1 · Canon Medical Informatics, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vitrea
    Primary DI
    00853866003247
    Version / Model
    6.9.1
    Company Name
    Canon Medical Informatics, Inc.
    Labeler DUNS
    160061651
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-23
    Public Version
    6
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    394b1aec-6a80-4d24-b957-2ff8ebeb8bab

    Device Description

    Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.

    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
    LLZ System, Image Processing, Radiological
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00853866003247