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510(k) Data Aggregation

    K Number
    K250911
    Date Cleared
    2025-10-17

    (205 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MOSkin radiation measurement system intended use is a dosimeter to measure radiation dose delivered by a radiation source to the location of an Radiation Dosimeter (RD) sensor on the patient in a clinical use environment. The system is intended for the verification of the output of radiation producing devices.

    The output of the system is not used to directly adjust the radiation dose to the patient.

    Device Description

    The Electrogenics Laboratories Ltd MOSkin Radiation Measurement System consists of the following components to provide secondary verification of dose from various radiotherapy and diagnostic imaging devices:

    • MOSFET (Si-based metal-oxide-semiconductor field-effect transistor) Dosimeter (RD) to record radiation during radiation exposure.
    • Reading device (HUB) for reading the radiation dose recorded by the dosimeter.
    • MOSkin Software Application, a simple software tool that the user interacts with for radiation dose calculation, dose reporting, managing and storing data.
    AI/ML Overview

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