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510(k) Data Aggregation

    K Number
    K042698
    Device Name
    UNFORS PATIENT SKIN DOSIMETER (PSD)
    Manufacturer
    Date Cleared
    2004-10-22

    (22 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNFORS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors.
    Device Description
    The Unfors Patient Skin Dosimeter (PSD) is a skin dosimeter to measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. The PSD can be equipped with 1-4 sensors. The PSD consists of several small (1-4) sensors on cables connected to a display unit. The sensors can be placed anywhere on the body and will leave a minimal footprint on the X-Ray image. The 1-4 sensors can independently measure dose. The PSD has two keys, ON/OFF and SELECT. The SELECT key is used to step through measured values and to enter software menus. An audio-visual 4 level warning system indicates to the user when specific dose levels are reached. The PSD is provided non-sterile and is not programmable. Thus, there is no software to be concerned with. Accessories that can/may accompany the PSD are an aluminum holder to hold the PSD to a patient side rail and a hard case to protect the PSD during shipping and storage. These are the only two accessories.
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