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510(k) Data Aggregation

    K Number
    K990335
    Date Cleared
    1999-09-09

    (218 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.

    Device Description

    The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.

    AI/ML Overview

    The provided text does not contain information regarding acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Philips Easy Vision Family Workstation Option Quantitative MT Analysis Package, primarily focusing on its description, intended use, and substantial equivalence to a predicate device, as determined by the FDA.

    Therefore, I cannot provide the requested information in the specified format from the given text.

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