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510(k) Data Aggregation

    K Number
    K203526
    Device Name
    C Scope Visualization System
    Manufacturer
    CIT Ortho
    Date Cleared
    2021-01-12

    (41 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIT Ortho

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The C Scope Visualization System is indicated to be used by a trained physician to provide illumination and visualization in arthroscopic procedures of an interior cavity of the body through a surgical opening.
    Device Description
    The C Scope Visualization System Includes the following components: Tablet with custom software for image/video processing and display, capture and USB data management, and external power supply Reusable handpiece with LED light source. Disposable single-use sterile kit including a semi-rigid scope with integral drape, and supplemental instruments including a cannula, trocar/obturator, and syringe and tubing for flushing.
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