BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QVCAD System Installation Kit

    DI: B630QVCSIK1010344 · Model: 10.10-3.4.4 · QVIEW MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QVCAD System Installation Kit
    Primary DI
    B630QVCSIK1010344
    Version / Model
    10.10-3.4.4
    Company Name
    QVIEW MEDICAL
    Labeler DUNS
    063962130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-06
    Public Version
    2
    Public Version Date
    2022-10-27
    Public Version Status
    Update
    Public Device Record Key
    b2be4708-0b7b-4247-a2f5-f9945a3c1940

    Device Description

    Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10

    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
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MYN Analyzer, Medical Image

    GMDN Terms

    Code Name
    40873 Ultrasound imaging system application software

    Identifiers

    Type ID
    Primary B630QVCSIK1010344
    Previous B630QVCSIK1010343

    Premarket Submissions

    Submission Number Supplement Number
    P150043 000
    P150043 001

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 90 Degrees Fahrenheit