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510(k) Data Aggregation

    K Number
    K981992
    Device Name
    ELECTRON WEDGE MODEL MT-EW-1000
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    1998-12-15

    (190 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECTRON WEDGE MODEL MT-EW-1000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of this device is to help provide dose uniformity for electron beam profile.

    Device Description

    MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the "Electron Wedge MT-EW-1000" by Med-Tec, Inc. It indicates that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is purely a regulatory clearance notice.

    Therefore, I cannot provide the requested information from the given input.

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