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510(k) Data Aggregation

    K Number
    K040687
    Device Name
    ONEDOSE PATIENT DOSIMETRY SYSTEM
    Manufacturer
    SICEL TECHNOLOGIES INC
    Date Cleared
    2004-06-25

    (101 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SICEL TECHNOLOGIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy applications.
    Device Description
    The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosimeters, (2) a hand held, battery powered, reader, and (3) a reader calibration test strip. The dosimeters use a metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and calibrated prior to use on a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The dose records are stored on the dosimeter for future reference and in the Reader's memory.
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