BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Viz LVO

    DI: 00811852030172 · Model: 1.10 · VIZ.AI, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Viz LVO
    Primary DI
    00811852030172
    Version / Model
    1.10
    Company Name
    VIZ.AI, INC.
    Labeler DUNS
    080594139
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-17
    Public Version
    3
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    18a26969-d71c-437c-9ad8-76f2a99edd9a
    Distribution End Date
    2020-06-01

    Device Description

    Viz LVO 1.10

    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
    QAS Radiological computer-assisted triage and notification software

    GMDN Terms

    Code Name
    57812 Radiology DICOM image processing application software

    Identifiers

    Type ID
    Primary 00811852030172
    Previous 00811852030134

    Customer Contacts

    Phone
    +1(415)663-6130
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    DEN170073 000