LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW

K023332 · GE Medical Systems · JAK · Oct 23, 2002 · Radiology

Device Facts

• Record ID: K023332
• Device Name: LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Oct 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.

Device Story

LightSpeed Ultra CT System with Wide-View option is a computed tomography X-ray system. Device consists of gantry, patient table, image acquisition hardware/software, and operator console. System captures X-ray data to produce cross-sectional images of head and whole body. Used in clinical settings by trained medical professionals. Output images are reviewed by physicians to assist in diagnostic decision-making. Modification of existing LightSpeed Ultra CT system; maintains same fundamental technology and intended use.

Clinical Evidence

No clinical data. Evaluation based on bench testing for electrical, mechanical, and radiation safety, confirming conformance to applicable medical device standards (UL2601-1, IEC 60601-1, 21 CFR Subchapter J).

Technological Characteristics

Computed tomography X-ray system. Materials and construction equivalent to predicate LightSpeed Ultra CT. Compliant with UL2601-1, IEC 60601-1, and 21 CFR Subchapter J. System includes gantry, patient table, and operator console. Software-based image acquisition.

Indications for Use

Indicated for head and whole body X-ray computed tomography applications in patients requiring diagnostic imaging.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• LightSpeed Ultra Computed Tomography System (K000300)

Submission Summary (Full Text)

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Ko2 3332

Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3, 2002

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.

OCT 2 3 2002 GE Medical Systems

> P.O. Box 414. W-1140 Milwaukee, WI 53201

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

| Submitter: | GE Medical Systems<br>PO Box 414<br>Milwaukee, WI 53201 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.<br>Senior Regulatory Programs Manager<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | October 2, 2002 |
| Device Name: | LightSpeed Ultra Computed Tomography System with Wide - View.<br>Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK |
| Marketed Device: | GE Medical System's LightSpeed Ultra Computed Tomography System<br>510(k) Number K000300, currently in commercial distribution. |

### Device Description:

The GE LightSpeed Ultra CT Scanner System with Wide - View is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Ultra CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.

#### Indications for Use:

The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.

## Comparison with Predicate Device:

The GE LightSpeed Ultra Computed Tomography System with Wide - View is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Ultra CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

#### Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

#### Conclusion:

Intended use and fundamental scientific technology are the same as the legally marketed GE LightSpeed Ultra CT System. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed Ultra CT System with Wide - View is substantially equivalent to the currently cleared LightSpeed Ultra CT System.

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Food and Drug Administration 200 Corporate Boulevard Rockville MD. 20850

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-1140 MILWAUKEE WI 53201

#### Re: K023332

Trade/Device Name: LightSpeed Ultra CT Scanner with Wide-View Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: October 3, 2002 Received: October 7, 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 vours,

Nancy C. Snogdon

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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al 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3. 2002

# STATEMENT OF INTENDED USE

510(k) Number (if known): ______________________________________________________________________________________________

Device Name: LightSpeed Ultra CT System with Wide - View

Indications for Use

The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.

(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_

Nancy C hogdon

510k) N E-2