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

K032490 · Toshiba America Medical Systems, In.C · LNH · Aug 21, 2003 · Radiology

Device Facts

• Record ID: K032490
• Device Name: TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 Story

EXCELART Vantage XGV/AGV is a 1.5T magnetic resonance imaging (MRI) system. It utilizes a short-bore magnet and gradient coil design with a wide, detachable patient couch. The system captures anatomical and functional MR data, including BOLD, perfusion, diffusion, and spectroscopy. It processes signals via a Xeon-based CPU to generate 2D/3D images. Operated by trained clinicians/technicians in a clinical setting, the system provides visual output for diagnostic interpretation. Key features include gating waveform display at the gantry, improved sequence performance, and updated SAR/dB/dt control to meet IEC 60601-2-33 standards. The device benefits patients by providing high-resolution diagnostic imaging for various body regions and clinical applications.

Clinical Evidence

Bench testing only. No clinical data provided. Performance parameters were compared to the predicate device (K023511), confirming no changes in imaging performance. Safety parameters (SAR, dB/dt) were validated against IEC 60601-2-33 (2002) standards.

Technological Characteristics

1.5T MRI system; short-bore magnet and gradient coil; Xeon-based CPU; wide detachable couch; RF coils (including 4ch flex body array and QD head SPEEDER); SAR limit 2.0 W/kg; dB/dt control per IEC 60601-2-33 (2002).

Indications for Use

Indicated for whole-body magnetic resonance imaging, including head, abdomen, pelvis, limbs, extremities, spine, neck, TMJ, heart, and blood vessels in patients requiring diagnostic imaging. Includes specialized applications like MRCP, MR angiography, BOLD, perfusion/diffusion, and proton spectroscopy.

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

• EXCELART with Pianissimo XG/AG SPIN Edition (K023511)

Reference Devices

• QD head SPEEDER (K022582)

Submission Summary (Full Text)

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AUG 2 1 2003

3.

Page 1 of 2

Appendix 1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|-------------------------|------------------------------------------------|
| Model Name: | MRT-1503/P3, P2 |
| Trade/Proprietary Name: | EXCELART Vantage ^™ XGV/AGV |

- 2. ESTABLISHMENT REGISTRATION: 2020563
TOSHIBA AMERICA MEDICAL SYSTEMS,INC. U.S. Agent Name and Address: 2441 MICHELLE DRIVE

TUSTIN, CA 92780

Michaela Mahl (714) 730 - 5000

Contact Person:

Manufacturing Site: TOSHIBA CORPORATION 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

- 5. DATE OF SUBMISSION: July 11, 2003
#### 6. 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. .

| Model Number with suffix | Trade/Proprietary Name |
|--------------------------|------------------------|
| MRT-1503/P3 | EXCELART Vantage™ XGV |
| MRT-1503/P2 | EXCELART Vantage™ AGV |

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K032490
Page 2 of 2

Appendix 1

## 6.1. SUMMARY OF MAJOR HARDWARE CHANGES

A. The magnet system was changed to short bore.

B. The gradient coil was changed to short bore.

C: The patient couch was changed to wide and detachable couch top.

D. It is possible to combine detachable couch top and gurney of exclusive use.

E. The whole body coil was modified for corresponds to SAR 2.0w/kg

F. 4ch flex body array coil is added in the optional items.

G. QD head SPEEDER (K022582) is added in the optional items.

H. The gating waveform can be displayed by the side of the gantry

## 6.2. SUMMARY OF MAJOR SOFTWARE CHANGES

- A. New CPU correspondence.
- B. New RF coils control.
- C. dB/dt limitation control.
- D. SAR limitation control.

## 7. SAFETY PARAMETERS

| | Current EXCELART™ with<br>Pianissimo XG/AG SPIN<br>Edition (No changes from the<br>previous submission,<br>K023511 ) | New EXCELART™<br>Vantage™<br>XGV/AGV |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted<br>acoustic noise: | 95.4 dB (A-weighted) | 110 dB (A-weighted) |
| c. Operational modes: | 1st operating mode for dB/dt<br>SAR, dB/dt | Same |
| i. Safety parameter display: | Same | Same |
| ii. Operating mode access<br>requirements: | Not applicable because used<br>only in normal operating<br>mode | Same |
| d. Maximum SAR | < 1.5 W/kg | < 2.0 W/kg |
| e. Maximum dB/dt | 46 T/sec | <1st operating mode<br>specified in IEC<br>60601-2-33 (2002) |
| and Gradient coil dimensions: | 1050 x 1175 x 50<br>(unit: mm) | 692 x 893 x 1405<br>(unit: mm) |
| f. Potential emergency<br>conditions and means provided<br>for shutdown: | Shut down by Emergency<br>Ramp Down Unit for collision<br>hazard by ferromagnetic<br>objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |

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#### 8. IMAGING PERFORMANCE PARAMETERS

No changes from the previous submission, K023511 .

### 9. INTENDED USE

No changes from the previous submission, K023511 .

### 10. EQUIVAALENCY INFORMATION

TOSHIBA Corporation Medical Systems Company believes that the new EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART™ with Pianissimo XG/AG SPIN Edition (model MRT-1501/P3, MRT-1501/P2) (K023511 ) cleared on November 05, 2002 except for new gantry and patient couch, new RF coils and dB/dt, SAR limitation.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Toshiba America Medical Systems, Inc. % Ms. Laura Danielson Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K032490

Trade/Device Name: Excelart Vantage™ XGV/AGV Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 11, 2003 Received: August 12, 2003

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment I

Page 1____ of ________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K1632490 |
|---------------------------|----------|
|---------------------------|----------|

Device Name: EXCELART Vantage™ XGV/AGV

Indications for 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 .

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

13

Prescription Use
(Per 21 CFR 801.109) ✓

Ohmil A. Sypon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)