LEGEND CRF FLUORO AND RAD SYSTEM

K993665 · Ge Medical Systems, Inc. · KPR · Nov 12, 1999 · Radiology

Device Facts

• Record ID: K993665
• Device Name: LEGEND CRF FLUORO AND RAD SYSTEM
• Applicant: Ge Medical Systems, Inc.
• Product Code: KPR · Radiology
• Decision Date: Nov 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Legend CRF Fluoro and Rad System is indicated for use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedures. This device is not intended for mammographic applications.

Device Story

Stationary X-ray system for general purpose radiographic and fluoroscopic imaging. Components include X-ray generator, angulating table, X-ray tube, collimator, image intensifier, and spot film device. Optional configurations include undertable bucky with ceiling-mounted tube hanger, basic radiographic table, or vertical bucky stand for chest/general procedures. Operated by clinical staff in diagnostic imaging environments. System generates X-ray beams to produce anatomical images for diagnostic review by physicians. Benefits include high-quality R&F imaging, patient positioning, and dose management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stationary X-ray system. Components: X-ray generator, angulating table, X-ray tube, collimator, image intensifier, spot film device, optional bucky stands. Standards: 21 CFR Subchapter J, UL 2601-1, IEC 60601-1, IEC 60601-2. Energy source: X-ray generation. Connectivity: Not specified.

Indications for Use

Indicated for general purpose radiographic and fluoroscopic X-ray diagnostic imaging of human anatomy. 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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993665

NOV 1 2 1999

Image /page/0/Picture/2 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.

GE Medical Systems

General Electric Company PO Box 414, Milwaukee, WI 53201

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 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: September 29, 1999 |
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| Identification of Product: | Legend CRF Fluoro and Rad System |
| Classification Name: | Stationary X-ray System |
| Manufacturer: | Medicor X-ray Co.<br>H-1097, Budapest<br>Illatos ut 9, Hungary |
| Device Description: | The Legend CRF Fluoro and Rad System consists of an X-<br>ray generator, angulating table with X-ray tube and<br>collimator, image intensifier and spot film device. Optionally,<br>the following items may also be part of the system:<br>-The table may be provided with an undertable bucky for use<br>with an X-ray tube mounted on a ceiling mounted X-ray tube<br>hanger.<br>-A basic radiographic table for use with an X-ray tube<br>mounted on a ceiling mounted X-ray tube hanger may be<br>included with the system.<br>-A separate, vertical bucky stand may also be provided for<br>chest or other general purpose radiographic procedures. |
| Indications for Use: | The Legend CRF Fluoro and Rad System is designed to<br>perform general purpose radiographic and fluoroscopic x-ray<br>examinations. This device is not intended for<br>mammographic applications. |
| Conformance: | The Legend CRF Fluoro and Rad System will conform to<br>applicable sections of 21CFR 1020.30, 1020.31, and<br>1020.32. The system will also conform to UL 2601-1. IEC<br>60601-1, and IEC 601-1-2. |
| Conclusions: | GE considers the Legend CRF Fluoro and Rad System to be<br>equivalent to other marketed devices with the same<br>indications for use and meeting similar standards. |

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### Statement of Indications for Use:

The Legend CRF Fluoro and Rad System is indicated for use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedures. This device is not intended for mammographic applications.

The Legend CRF Fluoro and Rad System consists of an X-ray generator, angulating table with X-ray tube and collimator, image intensifier and spot film device. Optionally, the following items may also be part of the system:

- The table may be provided with an undertable bucky for use with an X-ray tube . mounted on a ceiling mounted X-ray tube hanger.
- . A basic radiographic table for use with an X-ray tube mounted on a ceiling mounted Xray tube hanger may be included with the system.
- A separate, vertical bucky stand mav also be provided for chest or other general . purpose radiographic procedures.

#### Claims:

The Legend CRF Fluoro and Rad System provides excellent image quality, patient positioning, x-ray generation, operator control, system mainfenance and dose management. These features make the system easy to use and reliable, providing high quality R&F images.

This notification contains all of the information required by 21CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Reviewers Screening Checklist" is attached.

The subject device conforms to the following mandatory and voluntary standards:

- . 21CFR Subchapter J
- . UL 2601-1
- . IEC 60601-1
- . IEC 60601-2

The subject device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. The subject device is not a kit.

The above statements are accurate representations of this 510(k) premarket notification and of the device this firm intends to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted (21CFR 807.87(j)).

Manufacturer: General Electric Medical Systems

R. Dunville for.

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager

9/29/99 Date

Official Correspondent:

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Image /page/2/Picture/2 description: The image shows a black and white seal for the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is simple and iconic, representing the department's role in protecting the health and well-being of Americans.

NOV I 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems c/o Reiner Krumme TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470

Re: K993665 Trade Name: Legend CRF Fluoro and Rad System Requlatory Class: II Product Code: 90-KPR and 90-JAA Dated: October 21, 1999 October 29, 1999 Received:

Dear Mr. Krumme:

We have reviewed vour 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 (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 (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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt, 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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#### STATEMENT OF INTENDED USE

510(k) Number (if known): __ K993665

Device Name: Legend CRF Fluoro and Rad System

# Indications for Use

The Legend CRF Fluoro and Rad System is indicated for use in generating radiographic and fluoroscopic images of human anatomy in all general purpose X-ray diagnostic procedures. This device is not intended for mammographic applications.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use<br>(Per 21 CFR 801-109) | X |
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| | OR Over-The-Counter Use_ |

| | (Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices |
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510(k) Number K993665