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510(k) Data Aggregation

    K Number
    K021360
    Device Name
    SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2003-06-10

    (406 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry.

    The SDF will be used for 'relative' dosimetry.

    Device Description

    Scintillating Fiber Dosimeter (SFD)

    AI/ML Overview

    This document is a 510(k) clearance letter for the Scintillating Fiber Dosimeter (SFD). It does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory compliance.

    Therefore, I cannot provide the requested information based on the provided text.

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