BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Q Series Diagnostic Ultrasound System

    DI: 06945121400060 · Model: Q9 · CHISON Medical Technologies Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    29
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Q Series Diagnostic Ultrasound System
    Primary DI
    06945121400060
    Version / Model
    Q9
    Company Name
    CHISON Medical Technologies Co., Ltd.
    Labeler DUNS
    544914187
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    5
    Public Version Date
    2022-09-05
    Public Version Status
    Update
    Public Device Record Key
    c64d5cc9-60ab-4e14-8d8e-0135bf776612

    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
    Yes
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 06945121400060
    Package 06945121402330
    Package 06945121402323
    Package 06945121402316
    Package 06945121402309
    Package 06945121402170
    Package 06945121402163
    Package 06945121402156
    Package 06945121402149
    Package 06945121402132
    Package 06945121402125
    Package 06945121402118
    Package 06945121402101
    Package 06945121402095
    Package 06945121402088
    Package 06945121402071
    Package 06945121402064
    Package 06945121402187
    Package 06945121402194
    Package 06945121402200
    Package 06945121402217
    Package 06945121402224
    Package 06945121402231
    Package 06945121402248
    Package 06945121402255
    Package 06945121402262
    Package 06945121402279
    Package 06945121402286
    Package 06945121402293

    Premarket Submissions

    Submission Number Supplement Number
    K153085 000