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    K Number
    K964608
    Device Name
    MRT-35A V9.0
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Date Cleared
    1997-02-04

    (78 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K961842,K962138,K945798,K933018
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K961842, K962138

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

    Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR Fluoroscopy.

    Device Description

    The MRT-35A v9.0 is a modification of the MRT-35A system which uses a 0.35T superconducting magnet. The MRT-35A v9.0 is an incremental upgrade to an MRT-35A system which is configured with version 8 hardware and software. The 9.0 upgrade replaces the version 8 computer system. The computer architecture, operational characteristics and user software follow the same design considerations cleared by Flexart™ and Visart™ systems. This 9.0 upgrade makes no change to the MRT-35A version 8 series magnet, gradient system or coil set.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the MRT-35A v9.0 device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the MRT-35A v9.0 are implicitly defined by its equivalency to previously cleared devices (MRT-35A v8.0 and Flexart™) and its demonstrated adherence to "consensus standards requirements" for image quality. The performance is reported by comparing key safety and image performance parameters to these predicate devices.

    Acceptance Criteria CategorySpecific ParameterAcceptance Criterion (Implicitly based on Predicate Device Performance)Reported MRT-35A v9.0 Performance
    Safety ParametersMaximum static field strength0.35 T (MRT-35A v8.0) / 0.5 T (Flexart™)0.35 T
    Rate of change of magnetic field6.83 T/sec (MRT-35A v8.0) / 11 T/sec (Flexart™)6.83 T/sec
    Max. radio frequency power deposition0.34 W/kg (MRT-35A v8.0) /
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