LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993574
    Device Name
    OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Date Cleared
    2000-01-18

    (89 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K962933,K983110,K962138,K990260,K981475
    Why did this record match?
    Device Name :

    OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON

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

    Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] -Fluid Visualization -2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging - Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging - Additional indication for v3.3 {only} Perfusion/Diffusion Imaging -

    Device Description

    Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: - v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed - v3.1: Based on v2.5 (K990260) - v3.2: Based on v2.6 (K990260) - v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

    AI/ML Overview

    This 510(k) premarket notification describes an upgrade to an existing Magnetic Resonance Diagnostic Device, the OPART™ (Model MRT-600), to software versions v3.0, v3.1, v3.2, and v3.3, along with optional hardware items. The core of this submission is to demonstrate substantial equivalence to previously cleared versions and to justify new functionalities and increased safety parameters.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission focuses on safety parameters and imaging performance. The "acceptance criteria" appear to be specified maximums for safety and a general "specification volume" for imaging. The "reported device performance" is essentially that the device operates within these stated limits and produces sample images.

    ParameterAcceptance CriteriaReported Device Performance
    Maximum static magnetic field strengthSpecified (0.35 Tesla)0.35 Tesla (inherent to the device model)
    Rate of change of magnetic fieldSpecified (19 T/second)19 T/second (inherent to the device model)
    Maximum radio frequency power deposition (SAR)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1