CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM

K993645 · Ge Medical Systems, Inc. · JAK · Dec 21, 1999 · Radiology

Device Facts

• Record ID: K993645
• Device Name: CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
• Applicant: Ge Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The CT/e Computed Tomography system is intended for head and whole body x-ray computed tomography applications.

Device Story

CT/e Computed Tomography system is a head and whole body X-ray scanner; consists of gantry, patient support, operator console, and computer. Device utilizes solid-state detector technology to acquire X-ray data; processes data to generate tomographic images for diagnostic use. Operated by trained personnel in clinical settings. Output viewed by clinicians to assist in diagnostic decision-making. System design and performance characteristics are comparable to existing CT scanners, providing diagnostic imaging capabilities for patient assessment.

Clinical Evidence

Bench testing only. System verification and validation performed to ensure compliance with specifications, regulatory requirements, and user requirements. Adherence to UL/IEC/CSA standards confirmed.

Technological Characteristics

Head and whole body CT scanner; solid-state detector; operator console. Materials compliant with 21 CFR Subchapter J and IEC 60601-1. Energy source: X-ray. Design features similar to HiSpeed LX/i, FX/i, and DX/i series.

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

• HiSpeed LX/i, FX/i and DX/i (K980169)

Submission Summary (Full Text)

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DEC 2 | 1999

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GE Medical Systems

P.O. Box 414 Milwaukee, WI 53201

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

- Submitter: Larry A. Kroger Senior Regulatory Programs Manager who may be contacted at 414-544-3894 or FAX [phone] Summary prepared May 11, 1999 CT/e Computed Tomography scanner system Device Name:

| Device Name: | CT/e Computed Tomography scanner system. |
|----------------------|--------------------------------------------------------------------------------------|
| Classification Name: | Computed Tomography X-ray System |
| Manufacturer | GE-YMS<br>7-127 Asahigaoka 4-Chome<br>Hino-Shi, Tokyo, Japan 191 |
| Distributor | General Electric Medical Systems<br>3000 North Grandview Blvd.<br>Waukesha, WI 53188 |

#### Marketed Devices:

The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses.

#### Device Description:

The CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.

Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169)

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Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intuitive Operator Console with similar features to the HiSpeed LX/i, FX/i and DX/i (K980169).

# Indications for Use:

CT/e Computed Tomography system is indicated for head and whole body x-ray computed tomography applications.

## Comparison with Predicate Device:

It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source and radiation characteristics. It will comply with the x-ray performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards.

## Adverse Effects on Health:

Potential electrical, mechanical, fire and radiation hazards are identified in the attached Risk Analysis and controlled by:

- System verification and validation to insure performance to . specifications, regulatory requirements and user requirements.
- Adherence to Industry and International Standards (UL/IEC/CSA) ●

## Conclusions:

Use of the CT/e Computed Tomography system does not result in any new potential safety risks and performs as well as, or better than devices currently on the market.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DFC 21 1999

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems. Inc. P.O. Box 414, W-709 Milwaukee, WI 53201

Re:

K993645 CT/e Computed Tomography System Dated: October 25, 1999 Received: October 28, 1999 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 referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 notfication"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel S. Schultz, M.D.

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CT/e Computed Tomography system

Indications For Use:

The CT/e Computed Tomography system is intended 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)

Daniel G. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use