LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023207
    Device Name
    OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-10-09

    (14 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K993574,K993803,K002531
    Predicate For
    N/A
    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 ●
    • MR Angiography / MR Vascular Imaging .
    • . Water / Fat Imaging
    • Perfusion / Diffusion Imaging .
    Device Description

    The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems.

    AI/ML Overview

    The provided text describes a 510(k) submission for a Magnetic Resonance Diagnostic Device Accessory, the OPART™/Ultra, and its upgrade kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not present in the provided text.

    However, I can extract and present the information that is available.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly present "acceptance criteria" in a quantitative format for imaging performance. Instead, it compares safety parameters of the new device (OPART™/Ultra) against its predicate (OPART™) and other substantially equivalent devices. The "performance" here refers to physical and operational characteristics rather than diagnostic accuracy.

    ParameterOPART™ (Predicate, K993574)OPART™/Ultra (Reported Performance)
    Static field strength0.35 T0.35 T (Same)
    Peak acoustic noise108 dB115.4 dB
    A-weighted acoustic noise98.4 dB(A)102.5 dB(A)
    Operational modesNormal operating modeNormal operating mode (Same)
    Safety parameter displaySARSAR (Same)
    Operating mode access requirementsNot applicable (only normal operating mode)Not applicable (Same)
    Maximum SAR
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1