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510(k) Data Aggregation

    K Number
    K953759
    Device Name
    DIAGNOSTIC ULTRASOUND TRANSDUCER
    Manufacturer
    BIOSOUND, INC.
    Date Cleared
    1996-03-01

    (203 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K925486
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

    Device Description

    The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.

    AI/ML Overview

    The provided text is a Safety and Effectiveness Summary for an ultrasound transducer, outlining its features and comparing it to a predicate device for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill the request.

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