STARSPEED SERIES CT SCANNER SYSTEMS

K052855 · GE Healthcare · JAK · Oct 28, 2005 · Radiology

Device Facts

• Record ID: K052855
• Device Name: STARSPEED SERIES CT SCANNER SYSTEMS
• Applicant: GE Healthcare
• Product Code: JAK · Radiology
• Decision Date: Oct 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

Device Story

StarSpeed Series CT Scanner System is an evolutionary modification of the LightSpeed 5.0 platform. Device consists of a gantry, patient table, operator console, computer, and PDU. It acquires X-ray data for head and whole-body imaging, transforming signals into reconstructed images via integrated software. Used in clinical settings by trained healthcare professionals (radiologists/technicians) to assist in diagnostic decision-making. System incorporates hardware and functional features from previous LightSpeed 4.0, 3.0, and 2.0 systems. Output is viewed by clinicians to evaluate patient anatomy and pathology, facilitating diagnosis and treatment planning. Benefits include diagnostic imaging capabilities consistent with established CT technology.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, system verification, and validation to ensure performance meets specifications and regulatory standards.

Technological Characteristics

System includes gantry, patient table, operator console, computer, and PDU. Compliant with UL 2601-1, IEC 60601-1, and 21 CFR Subchapter J. Operates as a head and whole-body X-ray CT scanner. Materials and construction are equivalent to previously marketed GE CT systems.

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 5.0 (K030420)
• LightSpeed 4.0 (K013561)
• LightSpeed 3.0 (K002978)
• LightSpeed 2.0 (K000300)

Submission Summary (Full Text)

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321 2 8 2005

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**GE Healthcare**

3000 N. Grandview Blvd. W-1140
Waukesha, WI 53188

AZ

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter: Lekshmi Nair FCT Safety and Regulatory Engineer Tel: [phone], Fax: [phone] e-mail: [e-mail] Date Prepared: September 20, 2005

#### PRODUCT IDENTIFICATION

Name:

StarSpeed Series CT Scanner Systems

Classification Name:

Computed Tomography X-ray System 21CFR892.1750, 90-JAK

Manufacturer:

GE Medical Systems LLC (GE Healthcare) 3000 N. Grandview Blvd. Waukesha, WI 53188

GE YOKOGAWA MEDICAL SYSTEMS 7-127 Asahigaoka 4-chome Hino-shi, Tokyo, JAPAN 191

GE HANGWEI MEDICAL SYSTEMS CO., LTD. No.1, Yong Chang North rd. Beijing economic & technological development zone Beijing, PR CHINA 100176

Distributor:

Same as Manufacturer

Marketed Devices:

The StarSpeed Series CT Scanner Systems are of comparable type and substantially equivalent to GE's currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses, such as the previous LightSpeed CT Scanners.

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#### DEVICE DESCRIPTION

The StarSpeed Series CT Scanner Systems are composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system.

The StarSpeed Series is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 2601-1. IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.

#### Indications for Use:

The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

#### Comparison with Predicate:

StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system. It has the same technological characteristics and operating principles, is comparable in key safety and effectiveness and QA features, and uses the same basic design, construction, and materials.

In the opinion of GE Healthcare, the StarSpeed Series CT Scanner Systems are of comparable type and substantially equivalent to currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended uses. StarSpeed Series will be certified to comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular standards.

#### Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:

- System verification and validation to ensure performance to specifications. Federal ● Requlations, and user requirements.
- Adherence and certification to industry and international standards. (UL/CSA and IEC). ●

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### CONCLUSIONS

StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the latest features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system and does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the StarSpeed Series CT Scanner Systems to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

A4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Co. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K052855

Trade/Device Name: StarSpeed Series CT Scanner System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 5, 2005 Received: October 11, 2005

Dear Mr. Borsai:

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 (Premarket Approval), 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 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 clectronic 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 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" (21 CFR 807.97). 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/cdrh/industry/support/index.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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## STATEMENT OF INTENDED USE

510(k) Number (if known): K052855

Device Name: StarSpeed Series CT Scanner System

### Indications For Use:

The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

-OR-

Over-The-Counter Use _

David R. Ingram

(Division Sign-Off) Division of Reproductive, and Radinlogical Device 510(k) Number

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