REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM

K992066 · GE Medical Systems · KPR · Aug 30, 1999 · Radiology

Device Facts

• Record ID: K992066
• Device Name: REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
• Applicant: GE Medical Systems
• Product Code: KPR · Radiology
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Revolution TX/i Digital Radiographic Table System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film / screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Device Story

Revolution TX/i Digital Radiographic Table System performs radiographic x-ray examinations; replaces film/screen systems. System components: elevating radiographic table with integrated amorphous silicon/cesium iodide digital detector, x-ray tube, tube hanger, collimator, system controller, generator; includes separate SG100 vertical bucky stand for chest/general procedures. Digital images transmitted via DICOM network for viewing, printing, storage. Used in clinical settings by healthcare professionals. Output provides diagnostic images for clinical decision-making; benefits include digital workflow efficiency and diagnostic capabilities equivalent or superior to film/screen.

Clinical Evidence

Bench testing only. Device evaluated for conformance with UL and IEC safety standards. No clinical data presented; equivalence established via technical comparison to predicate systems.

Technological Characteristics

Stationary X-ray system. Detector: amorphous silicon with cesium iodide scintillator. Components: elevating radiographic table, x-ray tube, collimator, generator, system controller. Connectivity: DICOM network. Safety: UL and IEC standards.

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.

Predicate Devices

• Digital Radiographic Imaging System (Revolution XQ/i) (K982196)
• Compax 40E table (K884930)

Reference Devices

• SCX (Advantx) radiographic system (K862120)
• Ultranet-SA Collimator (K894142)
• Maxiray 100 Radiographic Tube
• SCPU Generator (K940277)
• SG100 vertical bucky stand

Submission Summary (Full Text)

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GE Medical Systems

AUG 30 1999

f

General Electric Company PO Box 414, Milwaukee, WI 53201

K99 2066

# 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: June 15, 1999 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Revolution TX/i Digital Radiographic Table System |
| Classification Name: | Stationary X-ray System |
| Manufacturer: | GE Medical Systems<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53118 |
| Marketed Devices: | Digital detector (part of Digital Radiographic Imaging<br>System, renamed Revolution XQ/i system) (K982196);<br>SCX (Advantx) radiographic system (K862120);<br>Ultranet-SA Collimator (K894142); Maxiray 100<br>Radiographic Tube (Pre-amendment); SCPU Generator<br>(K940277) and SG100 vertical bucky stand (Pre-<br>amendment). |
| Device Description: | The Revolution TX/i Digital Radiographic Table System<br>is designed to perform radiographic x-ray examinations.<br>The detector is comprised of amorphous silicon with a<br>cesium iodide scintillator. The resulting digital image<br>can be sent through a DICOM network for applications<br>such as printing, viewing and storage. The Revolution<br>TX/i Digital Radiographic Table System consists of a an<br>elevating radiographic table with integrated digital<br>detector, x-ray tube, x-ray tube hanger, collimator,<br>system controller, and generator. A separate,<br>conventional SG100 vertical bucky stand is provided for<br>chest or other general purpose radiographic<br>procedures. |
| Indications for Use: | The Revolution TX/i Digital Radiographic Table System<br>is indicated for use in generating radiographic images<br>of human anatomy. It is intended to replace |

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radiographic film / screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

- Comparison with Predicate: The Revolution TX/i Digital Radiographic Table System is substantially equivalent to the Revolution XQ/i system, originally cleared as Digital Radiographic Imaging System in 510(k) K982196. The table used in the Digital Radiographic Table System is substantially equivalent to the Compax 40E table cleared in 510(k) K884930.
Summary of Studies: The device has the same detector and acquisition system as the predicate device, and the same intended uses. It will be evaluated for conformance with UL and IEC safety standards. We consider the device to be substantially equivalent to the predicate device.

GE considers the Revolution TX/i Digital Radiographic Conclusions: Table System to be equivalent with the predicate device. The TX/i Digital Radiographic Table System provides radiographic images that result in equivalent or better diagnostic capabilities than film / screen images. The potential hazards, e.g., wrong measurements and misdiagnosis, are controlled by a risk management plan including:

- · A Hazard Analysis
- · A Software Development and Validation Process
- · Certification to applicable UL and IEC safety standards
- · External evaluations

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 20 2013

Larry A. Kroger. Ph.D. Senior Regulatory Programs Manager General Electric Company PO Box 414 MILWAUKEE WI 53201

Re: K992066

Trade/Device Name: Revolution TX/I Digital Radiographic Table System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: June 17, 1999 Received: June 18, 1999

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of August 30, 1999.

We have reviewed vour 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### STATEMENT OF INTENDED USE

510(k) Number (if known): K992066

Device Name: Revolution TX/i Digital Radiographic Table System

# Indications for Use

The Revolution TX/ Digital Radiographic Table System is indicated for use in generating radiographic images of human anatomy. It is Intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

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OR Over-The-Counter Use_

David G. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number