BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    StrokeViewer

    DI: B037NLSVC0 · Model: NLSV-C · ResolutionMD Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    StrokeViewer
    Primary DI
    B037NLSVC0
    Version / Model
    NLSV-C
    Company Name
    ResolutionMD Inc.
    Labeler DUNS
    243325225
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-03
    Public Version
    1
    Public Version Date
    2024-10-11
    Public Version Status
    New
    Public Device Record Key
    dd2e490c-dc0d-440f-b325-e83bc62daf1b

    Device Description

    The device is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    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
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary B037NLSVC0