REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

K051967 · GE Healthcare · KPR · Aug 9, 2005 · Radiology

Device Facts

• Record ID: K051967
• Device Name: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
• Applicant: GE Healthcare
• Product Code: KPR · Radiology
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic Hevoldion AFVO Digital hadlographis maging System is manimographic applications.

Device Story

The Revolution XR/d with Tomosynthesis is a digital radiographic x-ray imaging system. It utilizes digital tomosynthesis acquisition techniques as a software option added to the existing Revolution XR/d platform. The system hardware includes an x-ray tube hanger, an overhead tube crane, and an elevating radiographic table with an integrated digital detector. It is operated by trained healthcare professionals in a clinical setting. The device captures x-ray projections to generate tomographic images, which are displayed for diagnostic review by a physician. These images assist in clinical decision-making by providing diagnostic information comparable to traditional linear tomographic devices.

Clinical Evidence

Clinical tests conducted under IRB authority compared the tomosynthesis diagnostic capability of the Revolution XR/d to the Tomo-Link linear tomographic device. Results indicated that the diagnostic capability of the subject device is as good as the predicate.

Technological Characteristics

Digital radiographic x-ray system; includes x-ray tube hanger, overhead tube crane, and elevating radiographic table with integrated digital detector. Utilizes digital tomosynthesis acquisition software. Conforms to applicable medical device safety standards for electrical, mechanical, and radiation safety.

Indications for Use

Indicated for use in generating tomographic images 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

• Revolution XR/d Digital Radiographic Imaging System (K012389)
• Tomo-Link (K944967)

Submission Summary (Full Text)

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051967

510(k) XR/d with Tomosynthesis GE Healthcare

AUG 9 - 2005

## Attachment B:

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

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The logo is black and white.

GE Medical Systems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

| Submitter: | GE Healthcare<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John L. Schmidt<br>Safety and Regulatory Engineering<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | July 15, 2005 |
| Device Name: | Revolution XR/d Digital Radiographic Imaging System with Tomosynthesis |
| Marketed Device: | Revolution XR/d Digital Radiographic Imaging System, 510(k) Number K012389<br>Tomo-Link, K944967, currently in commercial distribution. |

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conforms to applicable medical device safety standards, as confirmed by a Nationally Recognized Tes Laboratory.

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Clinical Tests: Clinical tests under the authority of an IRB show that Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device.

as good and other key features are consistent with traditional clinical proc.org fundamental scientific Condusion: Intended uses and only Key leatures and fundation des and fundamental scientified guidelines, and established Themods of patient excellent the Revolution XR/d Rediographic technology are the Same as the legally manufacturer conforms to 21 CFF 820,
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John L. Schmidt Safety and Regulatory Engineer GE Healthcare GE Medical Systems LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188

AUG 9 - 2005

Re: K051967

Trade/Device Name: Revolution XR/d with Tomosynthesis Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: KPR, MQB, and IZF Dated: July 15, 2005 Received: July 20, 2005

Dear Mr. Schmidt:

. "

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 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (o proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Revolution XR/d with Tomosynthesis

## Indications for Use

Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic Hevoldion AFVO Digital hadlographis maging System is manimographic 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_______________________________________________________________________________________________________________________________________________________

David A. Segerson
(Division Sign-Off)

(Division Sign-Off) Division of Renenduring Andominal and Padintoneal Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________