GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM

K041476 · Ge Medical Systems, LLC · LNH · Jun 17, 2004 · Radiology

Device Facts

• Record ID: K041476
• Device Name: GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The GE Signa® Excite MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa Excite MR system is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, and musculoskeletal regions of the body. The images produced by the Signa Excite system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Story

The GE Signa® Excite 1.5T and 3.0T MR systems are superconducting magnetic resonance scanners. They acquire 2D and 3D images and spectra by detecting the spatial distribution of protons (hydrogen nuclei) using magnetic resonance. The systems support 1, 4, 8, and 16 independent receive channels, with modular expansion capability in 16-channel increments. The device is operated by trained professionals in clinical settings to produce high-resolution anatomical images and spectroscopic data. These outputs are interpreted by physicians to assist in clinical diagnosis. The systems are designed for high signal-to-noise ratios and short scan times.

Clinical Evidence

Bench testing only. The systems were evaluated against IEC 60601-1 International Medical Equipment Safety Standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis.

Technological Characteristics

Superconducting magnet operating at 1.5T and 3.0T. Supports 1, 4, 8, 16 independent receive channels with modular expansion. Acquires 2D/3D images in sagittal, coronal, axial, oblique, and double oblique planes. Supports multinuclear spectroscopy. Complies with IEC 60601-1 and IEC 60601-2-33 standards.

Indications for Use

Indicated for use as a diagnostic imaging device for the entire body, including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, and musculoskeletal regions. Produces axial, sagittal, coronal, and oblique images and spectra to assist in diagnosis. For use by trained physicians.

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

• Signa® 1.5T Infinity MR system (K013636)
• Signa® 3.0T Infinity with Excite Technology MR System (K030874)

Submission Summary (Full Text)

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K041476

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GE Healthcare Technologies

P.O. Box 414, Milwaukee, WI 53201

# JUN 1 7 2004

## 510(k) Summary

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 Healthcare Technologies<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- 548-4768 |
| Date Prepared: | May 28, 2004 |

## Device Name:

GE Signa® Excite 1.5T MR System, and
GE Signa® Excite 3.0T MR System GL Signa "Exons C.o. P.M. System, 21 CFR 892.1000, 90-LNH

### Marketed Device:

The Signa® Excite 1.5T MR System is substantially equivalent to the currently marketed The Signa® 1.5T Infinity MR system (K013636) with the main differences being a change to the Signa - 1.51 millily Mil Dyoton (10 receive channels, and allows for future expansion in 16 channel increments.

The Signa® Excite 3.0T MR System is substantially equivalent to the currently marketed The Signa "Excite U.S.T. MIT System (K030874) with the main differences Sigra 5.01 minity with Exono Toonnelogy the Stateen independent receive channels, and allows for future expansion in 16 channel increments.

## Device Description:

The Signa® Excite 1.5T and 3.0T Magnetic Resonance Systems are a modification to the The Oight - Exole 110 Pana 2007 Mass 6, and K030874 which utilizes a superconducting previously cleared Mr Systems No roooo, and Roover images. The Signa® Excite magnet to acquire 2D Single and make and make a superconducting magnet operating at 1.51 and 0.0 r Magnolis (1600)and institution system supports 1, 4, 8, 16 independent receive channels and multiple independent coil elements per channel during a single acquisition channolo and manification is designed for expansion in 16 channel Sencs. The system can image in the sagittal, coronal, axial, oblique and double oblique increments. The system our mage in the sage are acquired and reconstructed using 2D and planes, asing ranous palos objaction. The system is intended for high-resolution anatomical applications, short scan times, and multinuclear spectroscopy.

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## GE Healthcare Technologies

P.O. Box 414, Milwaukee, Wi 53201

## Indications for Use:

The GE Signa® Excite MR system is a whole body magnetic resonance scanner designed to The GE Signa - Excite Mrs System is a wholo bout magnolo rean times. The Signal Excite MR
support high resolution, high signal-to-noise ratio, and short scan times. Costition system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal system is indicated for use as a diagnocto imaging spectra, dynamic images of the internal and oblique images, spectroscopic intagos, and or special, head, nead, neck, TMJ, spine, a structures and organs of the entire body, modale, blood vessels, and much as and only and breast, theat, abuonten, perio, jointo, proclare, and excite system reflect the spatial distribution of the body. The inhages produced by the elgha- Enence. These images and/or spectra when profons (rydrogon hadler) extraining may assist in diagnosis.

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## Comparison with Predicate Device:

The Signa® Excite 1.5T and 3.0T MR Systems are a modification of the previously cleared MR The Signa Excite 1.51 and 6.61 with the main differences being the change to the receive systems K015000, and 100007 exten independent receive channels, and allows for future expansion in 16 channel increments.

## Summary of Studies:

The Signa® Excite 1.5T and 3.0T Magnetic Resonance Systems were evaluated to the The Signa - Excite 1.0 Parks of Philaghts as well as the IEC 60601-1 International Medical appropriate NEWs porformance etanceres in 33 Particular Requirements for Safety of Equipment Salety Standard and 120 0000 - 12 Signal "Excite 1.5T Magnetic
Magnetic Resonance Equipment for Medical Diagnosis. The Signal "Excite 1.5T Magnetic Floonance System. The Signa® Excite 3.0T Magnetic Resonance System is comparable to the currently marketed Signa® 3.0T Infinity with Excite Technology Magnetic Resonance System.

## Conclusion:

It is the opinion of GE that the Signa® Excite 1.5T Magnetic Resonance System is substantially it is the Signa® 1.5T Infinity Magnetic Resonance System. Usage of the Signa equivalorit to the organice System does not result in any new potential hazards.

It is the opinion of GE that the Signa® Excite 3.0T Magnetic Resonance System is substantially it is the Signa" 3.0T Infinity with Excite Technology Magnetic Resonance System. Usage of the Signa® Excite 3.0T Magnetic Resonance System does not result in any new potential hazards.

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Food and Drug Administration 9200 Gorporate Boulevard Rockville MD 20850

# JUN 1 7 2004

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Healthcare Technologies P.O. Box 414 W-400 MILWAUKEE WI 53201

Re: K041476

Trade/Device Name: GE Signa® Excite 1.5T MR System, and GE Signa® Excite 3.0 MR Systen Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH

Dated: May 28, 2004 Received: June 3, 2004

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 for associated in 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 r ou may, there, manns 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has 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. Brigdon

Nancv 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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Ko41476

GE Healthcare Technologies P.O. Box 414, Milwaukee, WI 53201

# STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

#### GE Signa® Excite 1.5T MR System, and Device Name: GE Signa® Excite 3.0T MR System

# Indications for Use

The GE Signa® Excite MR system is a whole body magnetic resonance scanner designed The GE Signa Excile Mrs System is a whole boar light scan times. The Signal
to support high resolution, high signal-to-noise ratio, and short so produce axial to support high resolution, ngil signal-lo-rane, androing device to produce axial
Excite MR system is indicated for use as a diagnostic images, and/or spectra, dynamic Excite MH System IS indicated for use as a diagnose innages, and/or spectra, dynamic
sagittal, coronal and oblique images, spectroscopic inqueling, but not limi sagittal, coronal and oblique images, spectrosophy, including, but not limited to,
images of the internal structures and organs of the inite, inited vesels, and images of the internal structures and organs of the original , prostale , head, messels, and head, neck, TMJ, spine, breast, neat, abdoment, portly, positions
musculoskeletal regions of the body. The images produced by the Signal excites system musculoskeletal regions of the body. The integoe proclass as hibiting magnetic resonance.
reflect the spatial distribution of protons (hydrogen nucled information has reflect the spatial distribution of protons (hydrogen hastory only in of the mation that
These images and/or spectra when interpreted by a trained physician yield information may assist in diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801-109)

OR

Over-The-Counter Use_

David A. Anderson

5 . Xk) Number

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