OPART MRT-600

K962933 · Toshiba America Mri, Inc. · LNH · Oct 25, 1996 · Radiology

Device Facts

• Record ID: K962933
• Device Name: OPART MRT-600
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 25, 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: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

Device Story

OPART™ is a 0.35T open-architecture vertical-field superconducting MRI system. It acquires hydrogen-based magnetic resonance signals to produce 2D/3D anatomical images, MR angiography, and MR fluoroscopy. Operated by trained clinicians in a clinical setting, the device utilizes hardware and software architectures derived from the Flexart™ and Visart™ systems. The vertical field design facilitates improved patient access and siting compared to horizontal systems. Clinicians view reconstructed images to assess anatomical structures and pathology; the output supports diagnostic decision-making across various body regions. The system includes a manually controlled patient couch similar to the Access Compass Bed.

Clinical Evidence

Bench testing only. Performance demonstrated via sample phantom and clinical images. Conformance to consensus standards verified for Signal-to-Noise ratio, uniformity, slice profiles, geometric distortion, and slice thickness/interslice spacing.

Technological Characteristics

0.35T open-architecture vertical-field superconducting magnet. Hydrogen nuclei excitation. Gradient field strength below IEC standards. Patient couch with manual horizontal/lateral movement. Compatible with vertical-field surface coils. Software architecture follows established design considerations from Flexart™/Visart™ systems.

Indications for Use

Indicated for whole body diagnostic magnetic resonance imaging, including head, abdomen, heart, pelvis, spine, blood vessels, and extremities, for patients requiring anatomical visualization via 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

• Flexart™ (K962933)
• Access™ (K962933)

Reference Devices

• Visart™
• MRT-35A

Submission Summary (Full Text)

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OCT 25 1996

510(k) Summary

K962933

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. DEVICE NAME: Magnetic Resonance Device
Model Number: MRT-600
Trade/Proprietary Name: OPART™

2. ESTABLISHMENT REGISTRATION: 2936923

3. U.S. Agent Name and Address: TOSHIBA AMERICA MRI, INC.
280 Utah Ave.
South San Francisco, CA 94080

Contact Person: Steven M. Kay
[phone]

4. Manufacturing Site: Toshiba America MRI, Inc.
280 Utah Avenue
South San Francisco, CA 94080

5. DATE OF SUBMISSION: July 26, 1996

6. DEVICE DESCRIPTION
The OPART™ is a modification of the Flexart™ 0.5T system that employs a 0.35T open architecture vertical field superconducting magnet. The computer architecture, operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.

7. SAFETY PARAMETERS

| | OPART | Flexart | Visart |
| --- | --- | --- | --- |
| Maximum static field strength: | 0.35T | 0.5T | 1.5T |
| Rate of change of magnetic field (T = 1000ms): | 18.5 T/sec | 11 T/sec, | 13.3T/sec. |
| Max. Radio frequency power deposition: | <0.244W/kg | <0.256 W/kg | <0.4W/kg |
| Acoustic Noise levels: | 98.4 dB (A) | 100.2 dB (A) | 105.3 dB |
| | (Maximum) | (Maximum) | (Maximum) |

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510(k) Summary (cont'd)
SUMMARY OF SAFETY AND EFFECTIVENESS

## 8. IMAGING PERFORMANCE PARAMETERS

| Specification volume: | Head: | OPART
10cm dsv | Flexart
10.4cm dsv | Visart
16cm dsv |
| --- | --- | --- | --- | --- |
| | Body: | 20cm dsv | 10.4cm dsv | 28cm dsv |

Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing.

## 9. INTENDED USE

Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Nuclei excited: Hydrogen
Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

## 10. EQUIVALENCE INFORMATION

Toshiba America MRI, Inc. (TAMI) believes the OPART™ is substantially equivalent to the Flexart™ and Access™ diagnostic magnetic resonance systems because it consists of hardware and software modifications that do not introduce new questions of safety or efficacy, nor does it introduce new indications for use. OPART™ uses a superconducting magnet that has a static magnetic field less than that of the cleared Flexart™ and in the same orientation as the Access™. The gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the market. New surface coils for this system are designed to be compatible with the vertical field of the magnet, as compared with the horizontal field of the standard Flexart™ system. Toshiba has prior experience designing vertical field coils for its Access system. The new magnet offers siting, shipping and patient access advantages, but does not change the system's intended use. Good Manufacturing Practices requirements and software development procedures are unchanged from those already in effect for the Flexart™. The patient couch is similar to the cleared Compass Bed.

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