BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VidiStar PACS & DICOM Viewer Software

    DI: 00869047000431 · Model: 4.X.X · Fujifilm Healthcare Americas Corporation
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VidiStar PACS & DICOM Viewer Software
    Primary DI
    00869047000431
    Version / Model
    4.X.X
    Company Name
    Fujifilm Healthcare Americas Corporation
    Labeler DUNS
    603156043
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-27
    Public Version
    4
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    f017040c-95b4-4429-9193-d5559290269b

    Device Description

    The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQK Computer, Diagnostic, Programmable
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 00869047000431