JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X

K073081 · Toshiba America Medical Systems, In.C · LNH · Nov 21, 2007 · Radiology

Device Facts

• Record ID: K073081
• Device Name: JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Nov 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions. The software will be effective for any anatomies that can have the artifact caused by the physiologic motion such as below. - CSF flow - Abdominal or chest wall movement due to the breathing - A Respiratory movement on shoulders - A Uncontrolled movements due to the stroke, pediatic or uncooperative patients

Device Story

JET software is an accessory for EXCELART Vantage Atlas-Z/Atlas-X MRI systems; designed to mitigate motion-related artifacts and improve signal-to-noise ratio. Input consists of raw MRI data acquired during patient scanning; software applies specialized acquisition and reconstruction techniques to compensate for physiological motion (e.g., breathing, CSF flow, involuntary patient movement). Output is high-resolution anatomical MRI images with reduced motion degradation. Used in clinical radiology settings by trained MRI technologists/radiologists. Clinicians use these enhanced images to improve diagnostic clarity in patients prone to motion artifacts, such as pediatric or stroke patients. Benefit includes reduced need for repeat scans and improved diagnostic confidence.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of imaging performance parameters to the predicate device (K063361).

Technological Characteristics

Software-based image reconstruction enhancement for MRI systems. Operates as an integrated component of the EXCELART Vantage Atlas-Z/Atlas-X MRI platform. Utilizes proprietary motion-compensation algorithms to process raw MRI data. No changes to hardware or energy source (magnetic resonance).

Indications for Use

Indicated for patients requiring MRI imaging where physiologic motion (CSF flow, breathing, shoulder movement, or uncontrolled movement due to stroke, pediatric status, or lack of cooperation) causes image artifacts or degradation.

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-Z and Atlas-X (K063361)
• PROPELLER (K031230)

Submission Summary (Full Text)

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K073081
Page 1 of 2

Toshiba America Medical Systems, Inc.

510(k) Premarket Not JET Software for Excelart VantageTM Atlas-Z, Atlas-X

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name | Magnetic Resonance Diagnostic Device Accessory | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|--|
| Model Name: | MRT-1503/S5, MRT-1503/S3 | |
| Trade/Proprietary Name | JET Software for EXCELART™ Vantage Atlas-Z, Atlas-X | |
| 2. Establishment Registration No.: | 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>[phone] | |
| 4. Manufacturing Site: | Toshiba Corporation<br>Medical Systems Company<br>1385 Shimoishigami<br>Otawara-shi, Tochigi 32408550, Japan | |
| 5. Date of Submission: | October 26, 2007 | |

#### 6. DEVICE DESCRIPTION

JET software provides high-resolution anatomical images with minimal artifacts due to physiological motion, which is caused by movement of anatomical regions due to breathing, CSF flow or other involuntary movements and can interfere with image quality.

#### 6.1. Summary Of Major Hardware Changes

None

# 6.2. Summary Of Major Software Changes

Algorithm was modified to support a new combination of image acquisition and reconstruction techniques.

# 7. IMAGING PERFORMANCE PARAMETERS

No changes from the previously cleared K063361.

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Toshiba America Medical Systems, Inc.

510(k) Premarket Notification JET Software for Excelart Vantage™ Atlas-Z, Atlas-X

## 8. INTENDED USE

The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions. The software will be effective for any anatomies that can have the artifact caused by the physiologic motion such as below.

- > CSF flow
- > Abdominal or chest wall movement due to the breathing
- A Respiratory movement on shoulders
- A Uncontrolled movements due to the stroke, pediatic or uncooperative patients

# 9. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that the EXCELART Vantage Atlas-Z and Atlas-X (models MRT-1503/S5, MRT-1503/S3) Magnetic Resonance Imaging (MRI) System with JET software is substantially equivalent to the following:

- · EXCELART Vantage Atlas-Z and Atlas-X (models MRT-1503/55, MRT-1503/S3) cleared November 21, 2006 (K063361).
- · "PROPELLER" manufactured by GE Medical Systems cleared May 2, 2003 (K031230), which uses a similar technique to reduce the motion-related artifact.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

NOV 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073081

Trade/Device Name: JET Software for EXCELART Vantage Atlas-Z, EXCELART Vantage

Atlas-X

Regulation Number: 21 CFR 892.1000

Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH

Dated: October 31, 2007

Received: November 1, 2007

#### 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 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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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 (OS) 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 vours.

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 1

# Indications for Use

K073081 510(k) Number (if known): __

Device Name: JET Software for EXCELART Vantage Atlas-Z, EXCELART Vantage Atlas-X

Indications for Use:

The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions.

Imaging of:

Any anatomies that can have the artifact caused by the physiologic motion such as:.

- CSF flow .
- Abdominal or chest wall movement due to the breathing .
- Respiratory movement on shoulders .
- Uncontrolled movements due to the stroke, pediatric or uncooperative patients ●

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)

5

Lorai Móz

an-Off) (Division Division of Reproductive, Abdominal an Radiological Devices 510(k) Number