MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM

K012836 · GE Medical Systems · JAK · Sep 7, 2001 · Radiology

Device Facts

• Record ID: K012836
• Device Name: MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Sep 7, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.

Device Story

The LightSpeed Plus Mobile CT System is a mobile-configured X-ray computed tomography scanner consisting of a gantry, patient table, image acquisition hardware/software, and operator console. It functions by acquiring X-ray data to generate cross-sectional images of the head and body. Used in clinical environments, it is operated by trained healthcare professionals. The system provides diagnostic images to assist clinicians in medical decision-making. The mobile configuration allows for flexibility in clinical settings, potentially improving patient access to CT imaging.

Clinical Evidence

Bench testing only. The device was evaluated for electrical, mechanical, and radiation safety, conforming to applicable medical device safety and performance standards (UL2601-1, IEC 60601-1, and 21 CFR Subchapter J).

Technological Characteristics

Computed tomography X-ray system. Materials and construction equivalent to the predicate LightSpeed Plus CT Scanner. Compliant with UL2601-1, IEC 60601-1, and 21 CFR Subchapter J. System includes gantry, patient table, image acquisition hardware/software, and operator console. Mobile configuration.

Indications for Use

Indicated for head and whole body X-ray computed tomography applications in both mobile and fixed site environments.

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

• GE LightSpeed Plus Computed Tomography System (K000300)

Submission Summary (Full Text)

{0}------------------------------------------------

Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.

SEP = 7 2001

KO)2836

GE Medical Systems

P.O. Box 414, NB-918 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: | August 22, 2001 |
| Device Name: | LightSpeed Plus Mobile Computed Tomography System.<br>Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK |
| Marketed Device: | GE Medical System's LightSpeed Plus Computed Tomography System;<br>510(k) Number K000300, currently in commercial distribution. |

#### Device Description:

The GE LightSpeed Plus Mobile CT Scanner System 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 Plus 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 Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.

### Comparison with Predicate Device:

The GE LightSpeed Plus Mobile Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Plus 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 legally marketed GE LightSpeed Plus CT System. The design and development process of the manufacturer conforms with 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 Plus Mobile CT System is substantially equivalent to the currently cleared LightSpeed Plus CT System.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, with flowing lines connecting them. The symbol is positioned in the upper right quadrant of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 7 2001

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, NB-918 MILWAUKEE WI 53201

Re: K012836

LightSpeed Plus Mobil CT System (Computed Tomography X-Ray System) Dated: August 22, 2001 Received: August 23, 2001 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

#### Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the interest we nave revelved your Section 10(k) notication of their to make as a legally marketed predicate devices marked in interstated in substantially equivalent (or the motions to the Medical Device Amendments, or to devices that have been reclassified in commerce probl to May 28, 1970, the clasment and of the real of the et (Act). You may, therefore, market the besigniture accordance will the provisions of the Post, 2004, 2005 and s provisions of the Act include requirements for annual registration, the general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to subject to subject to subject to subject to subject to subject to su If your device is classilied (see above) more cass II (opedia Oone of Federal Regulations, Title 21, Partical Regulario Personal additional controls. Existing major regulations articles with the Current Good Manufacturing Practice requirements, 800 to 897. A substantaly equivalian assumination assumers of man and manufacturer (21 CFR Part 820) and the children may as set form in the Quality System Regulation (QS) to Medical Derices. Failure to comply with the UMP regulation may QS Inspections, the Food alle Drig Ammisstanon (1 Dr.) Virther announcements concerning your device in the Federal Register. Please result if regulation in addition rumission submission does not affect any obligation you might have under setions 531 through nove. uns response to your premation babinessen assomes on other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of the post I fills letter will allow your device to a legally marked 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, 4,xxx, 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 and all a reference to premarket notification" (21 CFR 807.97). Other general Alst, please not 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. Bk ogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Special 510(k) Premarket Notification Special 510(K) Premarket Notifioution
GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001

## STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LightSpeed Plus Mobile CT System

# Indications for Use

The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray
the states and while the subservation and as answere as a fixed The LightSpeed Plus CT Scanner System is indication for house of the mobile as well as a fixed site environment.

(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 broaden

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012836
510(k) Number.