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510(k) Data Aggregation

    K Number
    K080038
    Device Name
    VANTAGE TITAN, MODEL MRT-1504/S3
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-01-22

    (15 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K063361
    Why did this record match?
    Device Name :

    VANTAGE TITAN, MODEL MRT-1504/S3

    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 Cisternography, 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
    • Perfusion / Diffusion Imaging
    • Proton Spectroscopy
    Device Description

    The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.

    The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

    • Gantry bore diameter has been increased from 600mm to 690mm at bore center.
    • Maximum power of RF amplifier has been increased from 20KW to 35KW.
    • RF amplifier cabinet has been added.
    • Gradient power supply has been modified to increase the output current from 300A to 550A.
    • Transformer cabinet has been modified to cover the system power requirement.
    AI/ML Overview

    The provided 510(k) Premarket Notification for the Toshiba Vantage Titan MR system (K080038) does not describe acceptance criteria or a study proving that the device meets those criteria in the context of device performance regarding image quality or clinical efficacy.

    Instead, this submission is centered around demonstrating substantial equivalence to a previously cleared predicate device (EXCELART Vantage Atlas-X, K063361), following modifications to hardware and software. The primary focus is on ensuring that the modifications do not alter the system's safety parameters or intended use, and that imaging performance remains equivalent to the predicate.

    Here's a breakdown of the requested information based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria CategorySpecific Criteria (from predicate K063361, assumed to be met by Vantage Titan)Reported Device Performance (Vantage Titan)
    Safety Parameters
    Static field strength1.5 TSame (1.5 T)
    Peak and A-weighted acoustic noise110 dB (A-weighted)Same (110 dB)
    Operational modes1st operating mode for dB/dt and SARSame (1st operating mode)
    Safety parameter displaySAR, dB/dtSame (SAR, dB/dt)
    Operating mode access requirementsAllows access to 1st level operating modeSame (allows access to 1st level operating mode)
    Maximum SAR4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2002))Same (4W/kg for whole body)
    Maximum dB/dt
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