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510(k) Data Aggregation

    K Number
    K983110
    Device Name
    FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Date Cleared
    1999-02-25

    (174 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K973799,K962138,K970573,K965068
    Why did this record match?
    Device Name :

    FLEXART,FLEXART/HYPER, VISART, VISART/HYPER

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

    Imaging of:

    • The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
    • Fluid Visualization
    • 2D/3D Imaging
    • MR Angiography/MR Vascular Imaging
    • Blood Oxygenation Level Dependent (BOLD) Imaging
    Device Description

    This submission consists of a software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary relating to acceptance criteria and the study conducted:

    Disclaimer: The provided document (K983110) is a 510(k) Premarket Notification summary from 1998 for a software upgrade to existing Magnetic Resonance Diagnostic Devices (FLEXART™ and VISART™). It focuses on demonstrating substantial equivalence to previously cleared devices. It primarily discusses safety parameters and imaging performance specifications rather than a typical clinical study with acceptance criteria for a new AI/CAD device.

    This document predates widespread AI in medical imaging and the standard AI/CAD study structure. Therefore, many of the requested fields (like sample size for test/training sets, ground truth establishment methods, MRMC studies, effect sizes, and standalone performance) are not directly addressed in the provided text as they pertain to a different type of device evaluation.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given the nature of the document, the "acceptance criteria" are more akin to specifications that the software upgrade maintains, and the "reported device performance" indicates that these specifications are met or comparable to the predicate devices.

    Parameter/CriteriaAcceptance Criteria (V3.5 s/w)Reported Device Performance (V4.0 s/w)Outcome/Met?
    Safety Parameters
    Maximum static field strength (FLEXART™)0.5 T0.5 TMet
    Maximum static field strength (VISART™)1.5 T1.5 TMet
    Rate of change of magnetic field (FLEXART™)11 T/sec.11 T/sec.Met
    Rate of change of magnetic field (FLEXART™/Hyper)13.3 T/sec.13.3 T/sec.Met
    Rate of change of magnetic field (VISART™)13.3 T/sec.13.3 T/sec.Met
    Rate of change of magnetic field (VISART™/Hyper)19.5 T/sec.19.5 T/sec.Met
    Maximum RF power deposition (FLEXART™)
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