SILHOUETTE VR

K982955 · GE Medical Systems · KPR · Nov 4, 1998 · Radiology

Device Facts

• Record ID: K982955
• Device Name: SILHOUETTE VR
• Applicant: GE Medical Systems
• Product Code: KPR · Radiology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Device Story

Silhouette VR is a stationary X-ray system consisting of an integrated table, tube stand, under-the-table generator, power distribution unit, wall stand, dual focal spot X-ray tube, and operator's console. The device is operated by clinical staff in a diagnostic imaging environment to generate radiographic images of human anatomy. The system transforms electrical energy into X-ray radiation to capture anatomical images, which are then reviewed by healthcare providers to assist in clinical diagnosis. The device is intended for general purpose diagnostic procedures, excluding mammography.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stationary X-ray system; includes integrated table, tube stand, under-the-table generator, power distribution unit, wall stand, and dual focal spot X-ray tube. Conforms to 21 CFR 1020.30/31, UL 2601-1 (IEC 601-1, UL 187), and IEC 601-1-2 (EMC).

Indications for Use

Indicated for generating radiographic images of human anatomy for general purpose diagnostic procedures. Not for mammographic applications.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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NOV 4 1998 P O Box 414 Milwaukee WI 53201-041.

982955

## 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 Pat 807.87(h).

| Identification of Submitter: | Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>GE Medical Systems<br>Tel. [phone]<br>Summary prepared: 7 August, 1998 |
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Identification of Product: Silhouette VR

- Classification Name: Stationary X-ray System
- GE HuaLun Medical Systems Co., Ltd. Manufacturer: No. 11 Jiuzhong Road, Jiugong Zone. Daxing County, Beijing (100076) P.R. China
- The Silhouette VR consists of an integrated table and tube stand. Device Description: under-the-table generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
- Indications for Use: The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- The Silhouette VR will conform the applicable sections of 21CFR Conformance 1020.30 and 1020.31, and UL 2601-1 (which includes IEC 601-1 and UL 187). The Silhouette VR also meets the IEC 601-1-2 standard for EMC.
- GE considers the Silhouette VR to be equivalent with other Conclusions: marketed devices with the same indications for use and meeting similar standards.

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, with three curved lines forming the body and arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1998 NOV

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

K982955 Silhouette VR Dated: August 21, 1998 Received: August 24, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

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 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 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 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 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 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/odrividsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INTENDED USE

510(k) Nun ber (if known): K982955

Device Name: Silhouette VR

## Indications for Use

The Silhou ette VR is indicated for use in generating radiographic images of human anatomy in The Simot site VYT is Indicated for ass in generaling halls not intended for mammographic applicatior s.

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 |
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| | <div> <i>(Division Sign-Off)</i> </div> <div>Division of Reproductive, Abdominal, ENT, and Radiological Devices,</div> |
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| 510(k) Number | K982955 |