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510(k) Data Aggregation

    K Number
    K022585
    Device Name
    KIMAX QMA
    Manufacturer
    MEDICAL METRICS, INC.
    Date Cleared
    2002-10-11

    (67 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KIMAX QMA

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

    KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic .
    Information obout the matiative assessment of motion in radiographic ...
    Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.

    Device Description

    KIMAX QMA™ is a quantitative imaging software application.

    AI/ML Overview

    This section is not applicable since the provided text is a 510(k) clearance letter from the FDA, a regulatory document, and does not contain details about acceptance criteria, study methodologies, or performance metrics of a medical device. The letter primarily confirms that the device, KIMAX QMA™, is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include information on the technical studies or data that would typically prove a device meets specific acceptance criteria.

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