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510(k) Data Aggregation

    K Number
    K024085
    Device Name
    CCD CAMERA, MODEL PKP-06000-000
    Date Cleared
    2003-03-11

    (90 days)

    Product Code
    Regulation Number
    892.1620
    Why did this record match?
    Product Code :

    IZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
    Device Description
    This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
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    K Number
    K972130
    Device Name
    DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
    Manufacturer
    Date Cleared
    1997-10-09

    (125 days)

    Product Code
    Regulation Number
    892.1620
    Why did this record match?
    Product Code :

    IZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation. This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.
    Device Description
    The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machines utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. As with most major surgical equipment, X-ray machines cannot be sterilised. It would damage them, rendering them useless. The Disposable X-Ray Cover provides a sterile barrier between the patient and the X-ray machine. Contaminants from operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation.
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