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510(k) Data Aggregation

    K Number
    K202713
    Device Name
    TrueView 100 Pro
    Manufacturer
    CompAI Healthcare (Shenzhen) Co.,ltd
    Date Cleared
    2020-11-18

    (63 days)

    Product Code
    MWP
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CompAI Healthcare (Shenzhen) Co.,ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
    Device Description
    The TrueView 100 Pro is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The TrueView 100 Pro includes the following major components: a system monitor, touch-screen display, a touchpad, and an imaging cabinet. The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.
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