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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
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMECER S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the PET-Dose device. It confirms that the device has been cleared by the FDA as substantially equivalent to a predicate device.

    However, this document:

    • Does not contain detailed information about the acceptance criteria used in a study to validate the device's performance.
    • Does not describe a specific study (like a clinical trial or performance study) that proves the device meets any acceptance criteria.
    • Does not provide data on sample sizes, ground truth establishment, expert qualifications, or MRMC study results.

    Therefore, I cannot extract the information required to populate the table and answer the specific questions about the device's performance study from this document.

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