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510(k) Data Aggregation

    K Number
    K030066
    Device Name
    CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
    Manufacturer
    NUCLEAR ASSOCIATES
    Date Cleared
    2003-08-29

    (234 days)

    Product Code
    KPT
    Regulation Number
    892.1360
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    Applicant Name (Manufacturer) :

    NUCLEAR ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.
    Device Description
    The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
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