REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING

K042602 · Ge Medical Systems, LLC · MQB · Jan 13, 2005 · Radiology

Device Facts

• Record ID: K042602
• Device Name: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
• Applicant: Ge Medical Systems, LLC
• Product Code: MQB · Radiology
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Device Story

Image pasting application for Revolution XR/d Digital Radiographic Imaging System; allows operator to generate 2 to 5 sequential radiographic images; electronically joins images to create single electronic image; enables visualization of anatomy larger than detector surface (41 cm x 41 cm); replaces traditional method of using oversized film cassettes; operated by technician; output viewed by radiologist; facilitates clinical decision-making by providing longer, continuous radiographic view.

Clinical Evidence

Bench testing only. Device evaluated for electrical, mechanical, and radiation safety; conforms to applicable medical device safety standards. No clinical data required.

Technological Characteristics

Stationary x-ray system; solid-state x-ray detector (41 cm x 41 cm); software-based image stitching/pasting application; conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

Indications for Use

Indicated for generating radiographic images of human anatomy. Not for mammographic use.

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

• Revolution XR/d Digital Radiographic Imaging System (K012389)

Submission Summary (Full Text)

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K042602

JAN 1 3 2005

Special 510(k) Premarket Notification GE Medical Systems - Image Pasting

# Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/5 description: This document appears to be a submission form for GE Medical Systems. It includes the submitter's information, which is GE Medical Systems located in Milwaukee, WI. The contact person is Mark M Stauffer, who works in Safety and Regulatory Engineering, and their phone and fax numbers are listed. The document also mentions the device name, which is an image pasting application for the Revolution XR/d Digital Radiographic Imaging System, and the marketed device, which is the Revolution XR/d Digital Radiographic Imaging System with the 510(k) Number K012389.

Device Description: Image pasting allows the operator to generate 2 to 5 sequential radiographic images and electronically join them to create a single electronic mage.

Indications for Use: The Revolution XRVd is intended for use in generating radiographic Images of human anatomy. It is not intended for mammographic use.

Comparison with Predicate Device: Revolution XR/d and Revolution XR/d with image pasting application are used to generate radiographic invol and revolution XFU with image pasting application date digitally of at the users preference, on film. Each device has one solid state x-ray detector in the cabino x-adiation On occasion a sadiologic in thin. The detectors have a 41 cm by 41 cm surface for capturing x-radiation. On occasion a ratiologist desires a radiograph covering an area larger than that of the delector. Using Revolution XRVd (or any andographic system) and of the of the of
over oversized film Revolution XRVd (or any andiographic system) the techn oversized film cassette, on with either one wide-angle or several smaller overlapping exposures will be made. Using Revolution on the one one the technician will be able to make several digital exposures and electronically join them together for viewing as a single, longer radiograph.

The composition of the two systems is nearly identical. Modifications are made to Revolution XFVd to end of the more of the wo wo works to houly luential. Mounce to Revolune and

Summany of Studies: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms with applicable medical of thecated for thechanical, micrlancal, and radionally Recognized Test Laboratory.

## Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Mended uses and fundamental scientific technology are the same as the legally market Revolution XRd Radiographic Imaging System. The 13485 and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verifled through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Modical Systems that the modified medical device is substantially equivalent with respect to sthe and effectiveness to devices currently cleared for market including Revolution XRVd.

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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

Mr. Mark M. Stauffer Safety and Regulatory Engineer Diagnostic X-ray Engineering GE Medical Systems LLC P.O. Box 414 MILWAUKEE WI 53188

AUG 2 3 2013

Re: K042602

Trade/Device Name: Revolution XR/d Digital Radiographic X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 16. 2004 Received: December 17. 2004

Dear Mr. Stauffer:

This letter corrects our substantially equivalent letter of January 13, 2005.

We have reviewed your 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 nredicate 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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Special 510(k) Premarket Notification GE Medical Systems - Image Pasting

### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

K042602

Device Name: Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System

# Indications for Use

Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

(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_

Daniel A. Simon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic

**510(k) Number** K042602