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510(k) Data Aggregation

    K Number
    K223116
    Device Name
    8X-10-6XXX Camera Head
    Manufacturer
    Santa Barbara Imaging Systems
    Date Cleared
    2023-02-28

    (148 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA K223116 document is a clearance letter for the 8X-10-6XXX Camera Head, indicating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the supporting technical documentation submitted for 510(k) clearance, which is not part of this letter.

    Therefore, I cannot provide the requested information based on the given input.

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