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510(k) Data Aggregation

    K Number
    K970573
    Device Name
    FLEXART V3.5 SOFTWARE
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Date Cleared
    1997-07-21

    (157 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K962138
    Why did this record match?
    Device Name :

    FLEXART V3.5 SOFTWARE

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

    Imaging of:

    • The Whole Body (including head, abdomen, pelvis, limbs and extremities, joints, spine, neck, -TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR Frida, nours, ever a reasony, MR Myeiography, MR Myeiography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
    • Fluid Visualization -
    • 2D/3D Imaging .
    • MR Angiography/MR Vascular Imaging -
    Device Description

    This submission consists of two upgrades to the MRT-50GP/E2 (FLEXART™) and MRT-50GP/H2 (FLEXART™/Hyper) system. The first is the V3.5 software, which is an upgrade over the V3.1 software. The second is the introduction of phased array coils into the coil lineup.

    AI/ML Overview

    The provided K970573 document describes an upgrade to existing Magnetic Resonance Imaging (MRI) systems (FLEXART™/FLEXART™/Hyper V3.5 software and new phased array coils). This submission focuses on demonstrating substantial equivalence to a previously cleared device (FLEXART™ V3.1) and enhanced performance without introducing new safety or efficacy questions.

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of "acceptance criteria" against which the device's performance is strictly measured in a quantitative manner for clinical efficacy. Instead, it focuses on demonstrating that the updated system maintains or improves upon the performance of the predicate device (V3.1) and adheres to general MRI safety parameters and consensus standards.

    However, we can infer performance parameters that were evaluated for the upgrade:

    MetricAcceptance Criteria (Implied)Reported Device Performance (V3.5)
    Safety ParametersRemain similar or within acceptable limits of predicate device
    Max static field strengthMust be 1.5T1.5T (Same as V3.1)
    Rate of change of magnetic fieldMust be 11 (13.3)T/sec11 (13.3)T/sec (Same as V3.1)
    Max. Radio frequency power depositionMust be
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