HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS

K980169 · General Electric Co. · JAK · Apr 13, 1998 · Radiology

Device Facts

• Record ID: K980169
• Device Name: HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
• Applicant: General Electric Co.
• Product Code: JAK · Radiology
• Decision Date: Apr 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.

Device Story

The HiSpeed LX/i, FX/i, and DX/i systems are head and whole-body CT scanners. The system comprises a gantry, patient table, operator console, and computer. It utilizes X-ray radiation and solid-state detectors to acquire cross-sectional images of the human body. The device is operated by trained medical professionals in a clinical setting. The system processes raw X-ray data to reconstruct images for diagnostic review by physicians. These images assist in clinical decision-making by providing anatomical visualization. The device is intended to provide diagnostic information to benefit patient care through non-invasive imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, hazard analysis, and verification/validation to ensure compliance with established safety standards (UL 187, IEC 601-1).

Technological Characteristics

Computed tomography X-ray system consisting of gantry, patient table, console, and computer. Materials and construction are equivalent to K940606. Compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J. Utilizes solid-state detector technology.

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 CT/i (K940606)

Submission Summary (Full Text)

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K980169

GE Medical Systems

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------0x 414 11 Marikee NI 5320

APR 1 3 1998

# 510(k) Summary of Safety & Effectiveness

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

Submitter: Larry A. Kroger, Ph.D.

Regulatory Programs Manager Who may be contacted by telephone at 414-544-3894 or by FAX at 414-544-3863. Summary prepared 24 December 1997

Summary prepared 24 December 1999

## Product Identification

Name: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Classification Name: Computed Tomography X-ray System

| Manufacturer: | GE-YMS<br>7-127 Asahigaoka 4-Chome<br>Hino-Shi, Tokyo, Japan 191 | Distributor: | GE Medical Systems<br>3000 Grandview<br>Waukesha, Wi 53188 |
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#### Marketed Devices:

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is of comparable type and substantially equivalent to currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses.

#### Device Description:

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories.

Materials: Materials and construction are equivalent to the HiSpeed CT/i (K940606) and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.

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 CT / i (K940606).

#### Indications for Use:

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.

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## Comparison with Predicate:

It is the opinion of GE Medical Systems that the HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is of a 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.

#### Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:

- . System verification and validation to insure performance to specifications, Federal Regulations, and user requirements.
- Adherence to Industry and International Standards. (UL and IEC) .

### Conclusions:

Use of the HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 3 1998

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

Re:

K980169 HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Dated: January 12, 1998 Received: January 13,1 998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. 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 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). 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 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 (OS) 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 regulatory 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 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 notification" (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/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D 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: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems

Indications For Use:

The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of 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 CER 801-109)

Over-The Counter Use_ OR

Yand A. Hymm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number