MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1

K961238 · Toshiba America Mri, Inc. · LNH · Jun 28, 1996 · Radiology

Device Facts

• Record ID: K961238
• Device Name: MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart Nuclei excited: Hydrogen Diagnostic Use: 2D/3D Imaging, MR Angiography

Device Story

The MRT-50A/150A Software Upgrade 12.0/12.1 is a software and hardware enhancement for existing Toshiba MRI systems. The device processes magnetic resonance signals to generate diagnostic images. It introduces new sequences, including improved FastSE (Fast Spin Echo), FastIR (Fast Inversion Recovery), Multislab MRA (Magnetic Resonance Angiography), and STC (Short Time Constant) imaging. Version 12.1 includes hardware to increase slice capacity for FastSE sequences. Operated by trained MRI technologists in clinical settings, the system provides images for physician interpretation to aid in clinical diagnosis. The upgrade maintains existing safety parameters, including static field strength, dB/dt, and SAR levels, ensuring substantial equivalence to previous software versions while expanding imaging capabilities.

Clinical Evidence

Bench testing included phantom imaging to measure signal-to-noise ratios for all new sequences. Clinical images were presented to demonstrate the performance of new sequences (FastSE, FastIR, MRA, STC). No comparative statistical metrics (p-values, CIs) were provided; performance was evaluated against established baseline imaging capabilities of the predicate systems.

Technological Characteristics

MRI system software and hardware upgrade. Operates at 0.5T (MRT-50A) and 1.5T (MRT-150A). Static field and gradient systems remain unchanged. Acoustic noise levels: 80-105 dB. SAR: 0.3W/kg (50A) to 0.8W/kg (150A). Sequences: FastSE, FastIR, Multislab MRA, STC imaging. Connectivity: Integrated system software.

Indications for Use

Indicated for diagnostic 2D/3D imaging and MR angiography of the head, body, extremity, spine, neck, TMJ, and heart using hydrogen nuclei excitation.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MRT-50A/150A Software release V11.9 (K941864)
• MRT-50A Version 11.1 with Super Performance Package (K924808)
• MRT-150A Version 11.1 (K914012)
• MRT-150A with Super Performance Package (K925286)

Submission Summary (Full Text)

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TOSHIBA
TOSHIBA AMERICA MRI, INC.
280 UTAH AVENUE, SOUTH SAN FRANCISCO, CA 94080
PHONE: [phone]
K 961238
JUN 28 1996

# 510(k) Summary

## SUMMARY OF SAFETY AND EFFECTIVENESS

### MRT-50A/150A SOFTWARE UPGRADE 12.0 and MRT-150A SOFTWARE UPGRADE 12.1

1. **Model Name:** MRT-50A/MRT-150A
**Device Name:** Magnetic Resonance Device Accessory
**Trade/Proprietary Name:** MRT-50A/150A Upgrade 12.0, MRT-150A Upgrade 12.1

2. **Establishment Registration:** #2936923

3. **Name and Address:**
TOSHIBA AMERICA MRI, INC.
280 Utah Avenue
South San Francisco, CA 94080

**Contact Person:**
Steven M. Kay
[phone]

4. **DATE OF SUBMISSION:** March 27, 1996

5. **DEVICE DESCRIPTION**
The Software Version 12.0/12.1 Upgrade for the MRT-50A/MRT-150A adds new sequences and software enhancements to the existing MRT-50A/150A software version. Version 12.1 also adds a new hardware to increase the number of slices available for FastSE sequences.

6. **DEVICE CHARACTERISTICS:**
The V12.0/12.1 product is an upgrade to the MRT-50A/150A software release V11.9. V12.0/12.1 includes hardware upgrades, software changes and new sequences. The hardware upgrade in V12.1 increases the number of slices available for FastSE sequences. Version 12.0 software changes provide improved FastSE sequences and Multislab MRA. Version 12.1 software changes provide improved Fat Suppression sequences and STC Imaging.

7. **SAFETY PARAMETERS**

| | MRT-50A | MRT-150A |
| --- | --- | --- |
| Maximum static field strength: | 0.5T | 1.5T |
| There are no changes to B0 | | |
| Rate of change of magnetic field: | 7.5T/sec, τ = 1000ms | 7.5T/sec, τ = 1000ms |
| There are no changes to dB/dt | | |
| Radio frequency power deposition: | 0.3W/kg max SAR | 0.8W/kg max SAR |
| S.A.R. remains below the cleared levels. | | |
| Acoustic Noise levels: | 80 dB | 105 dB worst case
85 - 100 dB typical |

Acoustic noise data was measured in accordance with NEMA guidelines.

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# 510(k) Summary (cont'd)

## SUMMARY OF SAFETY AND EFFECTIVENESS
MRT-50A/150A SOFTWARE UPGRADE 12.0 and MRT-150A SOFTWARE UPGRADE 12.1

## 8. IMAGING PERFORMANCE PARAMETERS

| Specification volume: | MRT-50A | MRT-150A |
| --- | --- | --- |
| | Head: 14cmX14cmX14cm | 10cm dsv |
| | Body: 125mm diameter cross section X 250mm long | 20cm dsv |
| Signal to noise ratio: | Sample phantom images and clinical images were presented for all new sequences. Signal-to-noise ratios for each phantom image were given. Clinical studies were presented for all new sequences. | |
| Uniformity in three orthogonal planes: | Unchanged | |
| Slice Profile in three orthogonal planes: | Unchanged | |
| Geometric Distortion in three orthogonal planes: | Unchanged | |
| V12.0 and V12.1 do not change the gradient system, especially with regard to linearity.
It is the gradient linearity that affects geometric distortion. | | |
| Slice Thickness: | Not Applicable | |
| Interslice Spacing: | Not Applicable | |

## 9. INTENDED USE

Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Nuclei excited: Hydrogen
Diagnostic Use: 2D/3D Imaging, MR Angiography

## 10. EQUIVALENCE INFORMATION

Version 12.0/12.1 Upgrade for the MRT-50A/150A is substantially equivalent to the V11.9 Software release for the MRT-50A/150A. The 510(k) submission for V11.9 received FDA clearance on January 26, 1995 (K941864). Some of the scanning techniques require that the Super Performance Package be installed on the MRI system. Version 11.1 with the Super Performance Package was cleared for the MRT-50A in K924808. Version 11.1 was cleared for the MRT-150A in K914012. The MRT-150A with the Super Performance Package received market clearance in K925286.

Version 12.0/12.1 provides an improved selection of FastSE sequences, adds the FastIR technique and improves the performance of the Vascular Imaging Package. All safety and effectiveness attributes remain essentially unchanged.