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510(k) Data Aggregation

    K Number
    K032725
    Device Name
    MOSFET AUTOSENSE WIRELESS
    Manufacturer
    THOMSON & NIELSEN ELECTRONICS, LTD.
    Date Cleared
    2003-10-03

    (30 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K040687,K052118
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

    Device Description

    MOSFET AutoSense Wireless

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a medical device (MOSFET AutoSense Wireless) and its indications for use. It does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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