FLEXART V3.1 SOFTWARE

K962138 · Toshiba America Mri, Inc. · LNH · Dec 23, 1996 · Radiology

Device Facts

• Record ID: K962138
• Device Name: FLEXART V3.1 SOFTWARE
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 23, 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

FLEXART™ V3.1 is an MRI system upgrade (MRT-50GP/E2 and MRT-50GP/H1) for the existing FLEXART™ platform. The system uses magnetic resonance to acquire anatomical images of the head, body, extremities, spine, neck, TMJ, and heart. The E2 model introduces new application features (FastASE, QuadScan, MR Fluoroscopy, MSOFT, PASTA); the H1 model increases gradient field strength. Operated by trained clinical staff in a radiology setting, the device transforms magnetic resonance signals into diagnostic images. Output is viewed by physicians to assess anatomy and pathology, aiding clinical decision-making. Benefits include improved image quality and expanded scanning capabilities (e.g., fat suppression, fluoroscopy) compared to the base model. Patient safety is managed via acoustic noise protection.

Clinical Evidence

Bench testing only. Performance was validated using sample phantom images and clinical images for all new sequences. Conformance with consensus standards was demonstrated for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.

Technological Characteristics

Magnetic resonance imaging system; 0.5 T static field strength; gradient field strength up to 13.3 T/sec (τ=1000ms); RF power deposition <0.34 W/kg. Software version 3.1 includes new sequences (FastASE, QuadScan, MSOFT, PASTA). Operates on hydrogen nuclei excitation. Acoustic noise levels <100 dB(A).

Indications for Use

Indicated for whole-body diagnostic imaging, including head, abdomen, heart, pelvis, spine, blood vessels, and extremities, utilizing hydrogen nuclei excitation for fluid visualization, 2D/3D imaging, MR angiography, and MR fluoroscopy.

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-50GP FLEXART (K933018)

Reference Devices

• MRT-35A

Submission Summary (Full Text)

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DEC 23 1996
K962138

# 510(k) Summary

## SUMMARY OF SAFETY AND EFFECTIVENESS

1. Model Name: MRT-50GP/E2 and MRT-50GP/H1
Device Name: Magnetic Resonance Device
Trade/Proprietary Name: FLEXART™ V3.1

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 Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-Ken
Japan 324

5. DATE OF SUBMISSION: May 30 1996

6. DEVICE DESCRIPTION
Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat suppression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™.

7. SAFETY PARAMETERS

| | MRT-50GP | MRT-50GP/E2 | MRT-50Gf/H1 |
| --- | --- | --- | --- |
| Maximum static field strength: | 0.5 T | Same | Same |
| Rate of change of magnetic field (τ = 1000ms): | 11 T/sec, | Same | 13.3 T/sec. |
| Max. Radio frequency power deposition: | <0.256 W/kg | Same | <0.34 W/kg |
| Acoustic Noise levels: | 100.2 dB (A) | Same | 98.5 dB (A) |
| | (Maximum) | (Maximum) | (Maximum) |

Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning, thus ensuring that the patient observed noise level is significantly below 100 dB (A).

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

## 8. IMAGING PERFORMANCE PARAMETERS

| Specification volume: | Head: | MRT-150A | MRT-150/H1 | MRT-150/F1 |
| --- | --- | --- | --- | --- |
| | | 10.4 cm dsv | 14 cm dsv | 14 cm dsv |
| | Body: | 10.4 cm dsv | 28 cm dsv | 28 cm 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 Medical Systems, Inc. (TAMS) believes the FLEXART™ and FLEXART™/HYPER systems with V3.1 are substantially equivalent to the MRT-50GP FLEXART™ because they consist of hardware and software upgrades that improve the performance of the basic FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ was cleared by K933018. The increased 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 received prior market clearance from the Agency. Software upgrades provide for improved image quality, but do not change the intended uses of the device. MR Fluoroscopy is similar to the same function that was cleared for the MRT-35A. Good Manufacturing Practices requirements are unchanged from those already in effect for the FLEXART™.

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