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510(k) Data Aggregation

    K Number
    K173848
    Device Name
    Model WP-3840 and WP-3040
    Manufacturer
    Date Cleared
    2018-08-07

    (231 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CNMC Co., Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 1D Water Phantom WP-3840 and WP-3040 is used to position various radiation detectors in water or air. It consists of a cubic acrylic tank and a precision one-dimensional hand crank. By design it is suitable to act as a phantom according to various protocols such as the AAPM's TG-51protocol.
    Device Description
    The Water Phantom WP-3840 and WP-3040 comprises of a one-dimensional precision mechanism attached to an Acrylic water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs. The WP-3840 and WP-3040 consist of the basic acrylic water tank phantom, equipped with a hand crank to move the detector. That hand crank is coupled to a mechanical counter, reset-able position indicator that displays the depth.
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