VANTAGE TITAN, MODEL MRT-1504/S3

K080038 · Toshiba America Medical Systems, In.C · LNH · Jan 22, 2008 · Radiology

Device Facts

• Record ID: K080038
• Device Name: VANTAGE TITAN, MODEL MRT-1504/S3
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Jan 22, 2008
• 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 Cholangiopancreatography), 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

Vantage Titan is a 1.5 Tesla MRI system featuring a 1.4m short magnet and Pianissimo scan noise reduction technology. It captures magnetic resonance signals to produce diagnostic images of the whole body. Operated by trained clinicians in a clinical setting, the system processes raw MR data to generate 2D/3D images, angiography, and spectroscopy. Output is displayed for physician review to assist in clinical diagnosis. Modifications from the predicate include an increased gantry bore diameter (690mm), higher RF amplifier power (35KW), and increased gradient power supply (550A). These changes facilitate patient access and imaging performance while maintaining established safety parameters for SAR and dB/dt.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of hardware/software modifications against the predicate device.

Technological Characteristics

1.5 Tesla MRI system; 1.4m short magnet; 690mm gantry bore; 35KW RF amplifier; 550A gradient power supply. Features Pianissimo noise reduction. Software controls include over-temperature protection, distortion correction, and SAR control databases. Operates under IEC 60601-2-33 (2002) safety standards for SAR and dB/dt.

Indications for Use

Indicated for whole-body MRI imaging, including head, abdomen, pelvis, limbs, spine, neck, TMJ, heart, and blood vessels, for patients requiring diagnostic imaging via 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 Vantage Atlas-X MRI System (K063361)

Submission Summary (Full Text)

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Toshiba America Medical Systems, Inc.

K080038
pg 1 of 3
510(k) Premarket Notification
Vantage Titan
TM

JAN 22 2008

## 510(k) SUMMARY

1. DEVICE NAME:

Model Name:

4.

Trade/Proprietary Name:

Magnetic Resonance Diagnostic Device Accessory MRT-1504/S3 Vantage Titan

#### 2. ESTABLISHMENT REGISTRATION: 2020563

| 3. U.S. Agent Name and Address: | Toshiba America Medical Systems, Inc.<br>2441 Michelle Drive<br>Tustin, Ca 92780 |
|---------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Paul Biggins<br>(714) 730 - 5000 |

TOSHIBA CORPORATION MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

#### 5. DATE OF SUBMISSION: December 19, 2007

#### 6. DEVICE DESCRIPTION

Manufacturing Site:

The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.

The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

- · Gantry bore diameter has been increased from 600mm to 690mm at bore center.
- · Maximum power of RF amplifier has been increased from 20KW to 35KW.
- · RF amplifier cabinet has been added.
- · Gradient power supply has been modified to increase the output current from 300A to 550A.
- · Transformer cabinet has been modified to cover the system power requirement.

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K080038
pg. 2 of 3

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Vantage TitanTM

## 6.1. SUMMARY OF MAJOR HARDWARE CHANGES

- a. Gradient coil has been modified to increased the inside diameter.
- b. WB coil has been modified to increased the inside diameter.
- Maximum power of RF amplifier has been increased from 20KW to 35KW. C.
- d. RF amplifier cabinet has been added.
- Gradient power supply has been modified to increase the output current from 300A to e. 550A.
- f. Transformer cabinet has been modified to cover the system power requirement.

### SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.

- a. New RF amplifier cabinet control.
- b. New gradient power supply control.
- C. Add the over temperature protection inside the gantry bore.
- d. Modified the data base for distortion correction for new gradient coil.
- e. Modified the data base for SAR control for new WB coil.

| | Current EXCELART Vantage<br>Atlas-X (No changes from the<br>previous submission, K063361 ) | New Vantage Titan |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted acoustic<br>noise: | 110 dB (A-weighted) | Same |
| c. Operational modes: | 1st operating mode for dB/dt and<br>SAR | Same |
| i. Safety parameter display: | SAR, dB/dt | Same |
| ii. Operating mode access<br>requirements: | Allows access to 1st level operating<br>mode | Same |
| d. Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33 (2002)) | Same |
| f. Maximum dB/dt | <1st operating mode specified in<br>IEC 60601-2-33 (2002) | Same |
| and Gradient coil dimensions: | 692 x 893 x 1405<br>(unit: mm) | 760 x 893 x 1405<br>(unit: mm) |
| f. Potential emergency conditions<br>and means provided for<br>shutdown: | Shut down by Emergency Ramp<br>Down Unit for collision hazard by<br>ferromagnetic objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |

#### 7. SAFETY PARAMETERS

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K080038
pg. 3 of 3

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Vantage TitanTM

### IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K063361.

#### INTENDED USE 9.

No changes from the previous submission, K063361.

# 10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that the new Vantage Titan (model MRT-1504/S3) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage Atlas-X (model MRT-1503/S3) (K063361) cleared on November 21, 2006.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

Re: K080038

Trade/Device Name: Vantage Titan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 4, 2008 Received: January 7, 2008

### Dear Mr. Job:

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, 1796, 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 such 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.

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Enclosure

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/cdrb/industry/support/index.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

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Indications for Use

510(k) Number (if known):

Device Name: Vantage Titan_

Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, 0 neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), 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 G
- . Proton Spectroscopy

Prescription Use (Part 21 CFR 801Subpart D)

OR

Over-The-Counter Use (Part 21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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