TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2

• K Number: K032490
• Device Name: TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
• Manufacturer: TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
• Date Cleared: 2003-08-21 ( 9 days)
• Product Code: LNH
• Regulation Number: 892.1000
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K022582 , K023511

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 Cholanqiopancreatography), 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 EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

• New gantry design as Ultra-short bore. .
• . New patient couch design as wide couch top.
• It is possible to combine detachable couch top and gurney of exclusive use. .
• . The CPU of computer system was changed from RISC type to Xeon.
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
• . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
• The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
• The gating waveform can be displayed by the side of the gantry. .

AI/ML Overview

This document describes a 510(k) submission for the EXCELART Vantage™ XGV/AGV MRI system. The submission focuses on demonstrating substantial equivalence to a predicate device, the EXCELART™ with Pianissimo XG/AG SPIN Edition.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the safety and imaging performance parameters of the new device to its predicate. The acceptance criteria essentially align with maintaining or improving upon the predicate device's specifications, particularly within regulated safety limits.

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (New Device)
Safety Parameters
Static field strength	1.5 T	Same (1.5 T)
Peak & A-weighted acoustic noise	95.4 dB (A-weighted)	110 dB (A-weighted)
Operational modes	1st operating mode for dB/dt, SAR, dB/dt	Same
Safety parameter display	Same	Same
Operating mode access requirements	Not applicable (used only in normal operating mode)	Same
Maximum SAR

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.