EXCELART VANTAGE ATLAS, MODEL MRT-1503

K063361 · Toshiba America Medical Systems, In.C · LNH · Nov 21, 2006 · Radiology

Device Facts

• Record ID: K063361
• Device Name: EXCELART VANTAGE ATLAS, MODEL MRT-1503
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Nov 21, 2006
• 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

1.5T MRI system; 1.4m short magnet; 655mm wide bore; Pianissimo noise reduction. Inputs: RF signals from patient anatomy via phased array coils. Transformation: 16-channel phased array control; enhanced CPU processing; gradient coil spatial encoding. Output: Diagnostic MR images. Used in clinical radiology settings; operated by trained technologists/radiologists. Output viewed on workstation; assists in anatomical/pathological diagnosis. Benefits: High-resolution imaging with reduced acoustic noise and expanded patient access via wide bore.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by hardware/software design verification and compliance with IEC 60601-2-33 (2002) for SAR and safety parameters.

Technological Characteristics

1.5T MRI; 1.4m magnet; 655mm bore. 16-channel phased array system. Materials: Standard medical-grade MRI components. Energy: RF and magnetic fields. Connectivity: Networked workstation. Sterilization: N/A. Software: Embedded control system for 16-channel phased array, SAR limitation, and couch control. Conformance: IEC 60601-2-33 (2002).

Indications for Use

Indicated for whole-body MRI imaging, including head, abdomen, pelvis, extremities, spine, neck, TMJ, heart, and vasculature. Supports 2D/3D imaging, angiography, BOLD, perfusion/diffusion, and proton spectroscopy. No specific age or gender contraindications listed.

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 ZGV MRI System (K060003)

Submission Summary (Full Text)

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K06336/

510(k) Premarket No Excelart Vantage™ Atlas Z, Atlas X

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 2 1 2006

| 1. Device Name | Magnetic Resonance Diagnostic Device Accessor | |
|------------------------------------|-----------------------------------------------|--|
| Model Name: | MRT 1503/S5, MRT-1503/S3 | |
| Trade/Proprietary Name | EXCELART Vantage Atlas-Z, Atlas-X | |
| 2. Establishment Registration No.: | 2020563 | |
| 3. U.S Agent Name and Address: | Toshiba America Medical Systems, Inc. | |
| | 2441 Michelle Drive | |
| | Tustin, CA 92780 | |
| Contact Person: | Paul Biggins | |
| | [phone] | |
| 4. Manufacturing Site: | Toshiba Corporation | |
| | Medical Systems Company | |
| | 1385 Shimoishigami | |
| | Otawara-shi, Tochigi 32408550, Japan | |
| 5. Date of Submission: | November 1, 2006 | |

## 6. DEVICE DESCRIPTION

The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.

There are two models in the EXCELART Vantage Atlas line as follows:

| • EXCELART Vantage Atlas-Z | Model No. MRT-1503/S3 |
|----------------------------|-----------------------|
| • EXCELART Vantage Atlas-X | Model No. MRT-1503/S3 |

The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:

- . 16 Channel phased array system control
- . CPU performance of the computer system has been enhanced
- The longitudinal movement of the patient couch has been increased
- . Additional table top coil ports
- . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
- SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)

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# 6.1. Summary Of Major Hardware Changes

- a. Maximum supported phased array channel has been increased from 8 to 16.
- b. CPU performance of computer system has been enhanced.
- c. Patient couch longitudinal movement has been increased.
- d. Table top coil ports have been added.
- e. Atlas SPEEDER Head and Atlas SPEEDER Spine and Atlas SPEEDER Body are added to the available coil list.

## 6.2. Summary Of Major Software Changes

- a. 16 channel phased array system control.
- b. New CPU correspondence.
- c. New patient couch control.
- d. New RF coil control.
- e. SAR limitation control.

#### 7. SAFETY PARAMETERS

| | Current EXCELART Vantage™<br>ZGV (No changes from the<br>previous submission, K060003 ) | New EXCELART<br>Vantage<br>Atlas-Z/Atlas-X |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 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 | 3W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33 (2002)) | 4W/kg for whole body<br>(1st operating mode<br>specified in IEC<br>60601-2-33 (2002)) |
| e. Maximum dB/dt and Gradient<br>Coil Dimensions: | <1st operating mode specified in<br>IEC 60601-2-33 (2002)<br>692 x 893 x 1405<br>(unit: mm) | Same |
| 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 |

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# 8. IMAGING PERFORMANCE PARAMETERS

No changes from the previous submission, K060003 .

# 9. INTENDED USE

No changes from the previous submission, K060003 .

## 10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that the new EXCELART Vantage Atlas-Z and Atlas-X (model MRT-1503/S3, MRT-1503/S3) Magnetic Resonance Imaging (MRI) system are substantially equivalent to the current EXCELART Vantage™ ZGV (model MRT-1503/PS) (K060003 ) cleared on January 18, 2006.

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN..." arranged around the left side of the circle. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers. The image is black and white and appears to be a scan or photocopy, given the slightly rough texture and uneven contrast.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV 2 1 2006

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 26th Street NW BUFFALO MN 55313

Re: K063361

Trade/Device Name: EXCELART Vantage Atlas Model MRT-1503 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 4, 2006 Received: November 7, 2006

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, 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 Cometic 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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or has made a determination that your device complies with other requirements of the Act that . Federal statutes and regulations administered by other Federal agencies. You must or uny 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) I ms teter notification. The FDA finding of substantial equivalence of your device to a legally premiered 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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

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 1

Indications for Use

510(k) Number (if known):

Device Name: EXCELART Vantage Atlas-Z, EXCELART Vantage Altas-X

K063361

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 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 .

Prescription Use (Part 21 CFR 801Subpart D)

OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sion-Off Division of Reproductive, Ab and Radiological Devices 5 10lk) Number _