SIGNA 3.0T MAGNETIC RESONANCE SYSTEM

K022397 · GE Medical Systems · LNH · Aug 22, 2002 · Radiology

Device Facts

• Record ID: K022397
• Device Name: SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Aug 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

Device Story

Signa® 3.0T Magnetic Resonance System is a diagnostic imaging device producing transverse, coronal, sagittal, and oblique images of internal structures; supports high-resolution imaging and multinuclear spectroscopy. Device combines 3.0T Signa® VH/i MR system with 3.0T Signa® VH/i Transmit/Receive Body Imaging Coil. Operated by trained professionals in clinical settings. Output consists of MR images used by physicians to visualize internal anatomy for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Magnetic resonance diagnostic device (21 CFR 892.1000). System utilizes 3.0T magnetic field strength. Supports high-resolution imaging and multinuclear spectroscopy. Compatible with previously cleared software options, coils, and accessories.

Indications for Use

Indicated for diagnostic imaging of the neck, spine, abdomen, thorax, and extremities using the 3.0T Signa®VH/i MR Imaging System.

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

• 3.0T Signa® VH/i transmit/Receive Body Imaging Coil (K003613)
• 3.0 T Signa® VH/i system (K990550)

Submission Summary (Full Text)

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# GE Medical Svstems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

## 510(k) Summary

K022397

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

| Submitter: | GE Medical Systems<br>PO Box 414<br>Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.<br>Manager, Regulatory Programs |
| Telephone: | 262-544-3894 |
| Fax: | 262-544-3863 |
| Date Prepared: | July 16, 2002 |

### Device Name:

Signa® 3.0T Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

### Marketed Device:

The Signa® 3.0T Magnetic Resonance System is substantially equivalent to the currently marketed 3.0T Signa® VH/i transmit/Receive Body Imaging Coil (K003613) and the 3.0 T Signa® VH/i system (K990550).

### Device Description:

The Signa" 3.0T magnetic resonance system is a diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures of the head, neck, spine, abdomen/thorax and the extremities. The Signa® 3.0T system is designed to support high resolution imaging and multinuclear spectroscopy. Previously cleared software options, coils, and other accessories may be used with the Signa® 3.0T MR System.

#### Indications for Use:

The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

#### Comparison with Predicate Device:

The Signa® 3.0T Magnetic Resonance System is a modification of the 3.0T Signa® VH/i MR system (K990550) by combining the 3.0T Signa® VH/i T/R Body Imaging Coil (K003613) with the 3.0T Signa® VH/i MR system (K990550). It has the same basic technological characteristics, and, uses the

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General Electric Company P.O. Box 414, Milwaukee, WI 53201

same basic design, construction, and materials. It has the same intended use, and operating modes as the predicate device.

## Summary of Studies:

Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria.

### Conclusion:

The results of the testing described above demonstrate that the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2002

Larry Kroger, Ph.D. Regulatory Affairs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K022397

Trade/Device Name: GE Signa® 3.0T MR system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 LNH Dated: July 18, 2002 Received: July 23, 2002

Dear Dr. Kroger:

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 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 this 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" (21 CFR Part 807.97). 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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510(k) Number (if known): _ KO22397

Device Name: GE Signa® 3.0T Magnetic Resonance System

#### Indications For Use:

The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: overline;"></span> |
|----------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |

Nancy hogdon

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022397 |