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510(k) Data Aggregation

    K Number
    K042746
    Device Name
    PET-DOSE
    Manufacturer
    COMECER S.R.L.
    Date Cleared
    2004-11-22

    (49 days)

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

    COMECER S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay vials, syringes, and mainly capsules before administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta emitters used in PET diagnostics such as. 18F, 12N, 150, etc. PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.
    Device Description
    PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples.
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