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510(k) Data Aggregation

    K Number
    K032243
    Device Name
    MINICAT DENTOCAT
    Manufacturer
    XORAN TECHNOLOGIES, INC.
    Date Cleared
    2003-10-02

    (72 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K003787,K945375,K030450
    Predicate For
    K061834,K113421
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are from images taken during a rotational X-ray sequence. The MiniCAT™ is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

    Device Description

    The MiniCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational Xray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The MiniCAT™ can measure distances and thickness on two dimensional images. Images produced by the MiniCAT™ can be printed or exported on magnetic and optical media.

    The building blocks of the MiniCAT™ are a motorized scanning arm carrying an X-ray source and image detector, and a computer running the MiniCAT™ software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.

    AI/ML Overview

    The provided text describes the MiniCAT™ imaging device and its 510(k) submission to the FDA. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

    The document states that the MiniCAT™ "complies with the requirements of 21 CFR 807.87(h) and does not pose any new safety risks or effectiveness issues.". This is a regulatory statement confirming substantial equivalence to predicate devices, but it does not detail specific performance metrics, acceptance criteria, or a study to demonstrate these. The document focuses on device description, intended use, and comparison with predicate devices to establish substantial equivalence.

    Therefore, I cannot provide the requested table or details about a performance study based on the input given.

    Summary of missing information:

    • No acceptance criteria are mentioned.
    • No study proving the device meets acceptance criteria is described.
    • No performance metrics for the device are reported.
    • No sample size for test or training set, data provenance, expert qualifications, or ground truth methods are provided.
    • No multi-reader multi-case (MRMC) or standalone study details are available.
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