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510(k) Data Aggregation

    K Number
    K032594
    Device Name
    ONE DIMENSIONAL WATER PHANTOM, WP 1D
    Manufacturer
    WELLHOFER DOSIMETRIE
    Date Cleared
    2003-09-05

    (14 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K943199
    Predicate For
    K191821
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision onedimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.

    Device Description

    The Clinical Reference Dosimetry Phantom WP 1D comprises a one-dimensional precision servomechanism attached to a Perspex (PMMA) water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs.

    The "Manual Version" consists of the basic phantom, equipped with a self-locking hand crank to move the detector. That hand crank is coupled to a battery powered, reset-able position indicator that displays the depth.

    The "SCU Version" consists of the basic phantom, equipped with a motor/potentiometer device to move the detector. An electronic servo control unit (SCU) consisting of a handheld Remote Control and a Motor Control unit is used to position the detector to a user definable or stored depth.

    AI/ML Overview

    The provided text for device K032594 does not contain information about acceptance criteria or a study proving that the device meets such criteria. This document is a 510(k) summary for a clinical reference dosimetry phantom, which is a physical device used to position radiation detectors, rather than an AI/software device that would typically have performance metrics.

    The 510(k) summary focuses on:

    • Description of the Device: It details the physical components and modes of operation (manual or motorized).
    • Intended Use: It specifies that the device positions radiation detectors in water or air for dosimetric protocols and is to be used by experienced professionals.
    • Technological Comparison: It establishes substantial equivalence to a predicate device (MEDTEC Inc. Depth Dose Apparatus, K943199) based on similar design and function.

    Since this device is a physical phantom and not an AI/software product, the concepts of "acceptance criteria," "sample size for test set," "ground truth," "MRMC study," or "standalone performance" as they relate to AI/software performance evaluations are not applicable and are not discussed in this document.

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