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510(k) Data Aggregation

    K Number
    K133526
    Device Name
    MDIXON-QUANT
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Date Cleared
    2014-02-12

    (89 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K102344,K103411
    Why did this record match?
    Device Name :

    MDIXON-QUANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • · is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems
    • · is a non-invasive triglyceride fat fraction calculation
    • · is a 3D, single breath-hold acquisition and reconstruction technique
    • · allows for water-fat separation generating Water-only, Fat-only images as well as Out-phase and In-phase images
    • · is indicated for magnetic resonance imaging of the liver
    Device Description

    mDIXON-Quant acquisition and reconstruction is based on the mDIXON product developed previously. Acquisition relies on a gradient echo acquisition (FFE) including a large number of echoes (6 or more). Furthermore, mDIXON-Quant reconstruction includes the use of multiple spectral peaks of triglyceride fat, correction of the T2* confounding effect and reduction of T1 bias.

    mDIXON-Quant allows for water-fat separation and generates Water-only, Fat-only images as well as Out-phase and In-phase images synthesized from the Water and Fat images. Additionally, mDIXON-Ouant produces images representing triglyceride fat fraction as well as images representing transverse magnetization relaxation.

    The feature requires:

    • · Specific parameter settings for the mDIXON sequence, within cleared parameter limits, to acquire the MR signals
    • · A new calculation function to generate the new images for Fat Fraction, T2 *. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
    • · The new images need to be stored and displayed with the appropriate labels for Fat Fraction, T2 *, applying the facilities provided by the cleared platform.
    AI/ML Overview

    Here's a summary of the acceptance criteria and study information based on the provided text for the mDIXON-Quant device:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    FF accuracy ±3.5%FF accuracy is ±3.5% for both field strengths and all possible parameter combinations
    T2* range and reproducibility 1.5%T2* range and reproducibility is 1.5% for both field strengths
    No error messages during Acquisition and Reconstruction testingNo error messages displayed
    Scan time
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