DIGITAL RADIOGRAPHIC IMAGING SYSTEM

K982196 · GE Medical Systems · KPR · Oct 6, 1998 · Radiology

Device Facts

• Record ID: K982196
• Device Name: DIGITAL RADIOGRAPHIC IMAGING SYSTEM
• Applicant: GE Medical Systems
• Product Code: KPR · Radiology
• Decision Date: Oct 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Digital Radiographic Imaging 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

Digital Radiographic Imaging System performs radiographic examinations of human anatomy; replaces film/screen systems. System components: wallstand, tubestand, x-ray tube, collimator, system controller, generator, and digital detector. Detector utilizes amorphous silicon with cesium iodide scintillator to capture x-ray signals; converts to digital images. Images transmitted via DICOM network for printing, viewing, and storage. Used in clinical settings by healthcare professionals. Output provides diagnostic images for physician review to support clinical decision-making; benefits patient through improved or equivalent imaging performance compared to traditional film/screen methods.

Clinical Evidence

Clinical evaluation involved two radiologists at three hospitals reviewing 30 paired digital and film/screen images of representative anatomical areas. Results indicated digital images provided equivalent or better imaging performance than film/screen images.

Technological Characteristics

Stationary x-ray system. Detector: amorphous silicon with cesium iodide scintillator. Connectivity: DICOM network. Safety standards: UL2601-1, IEC601-1. Components: wallstand, tubestand, x-ray tube, collimator, system controller, generator, digital detector.

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

• Advantx Radiographic System (K862120)
• SG-60 vertical wallstand

Reference Devices

• Ultranet-SA Collimator (K894142)
• Maxiray 100 Radiographic Tube (K812915)
• SCPU Generator (K940277)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The letters and the circle are filled with a dark color, contrasting with the white background. The logo is positioned to the right side of the image.

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K982196

**GE Medical Systems**

General Linten Company P ( Box 11: Aldy Juker: 31: 3 . 81-9412

## 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: 19 June, 1998 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Digital Radiographic Imaging System |

Stationary X-ray System Classification Name: Manufacturer: GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53188

Marketed Devices: The SG60 vertical wallstand was pre-Amendment and the SCX radiographic system was introduced in 1986 (K862120). Subsequently, these were used with the Ultranet-SA Collimator (K894142), the Maxiray 100 Radiographic Tube (K812915), and the SCPU Generator (K940277).

- Device Description: The Digital Radiographic Imaging System is designed to perform radiographic examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage. The Digital Radiographic Imaging System consists of a wallstand, tubestand, x-ray tube, collimator, system controller, generator and digital detector.
- Indications for Use: The Digital Radiographic Imaging 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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Comparison with It is the opinion of GE Medical Systems that the Digital Predicate: Radiographic Imaging System is of comparable type and substantially equivalent to the Advantx Radiographic System (originally cleared as the SCX K862120) combined with a SG-60 vertical wallstand with respect to intended use, radiation characteristics and image quality. The Digital Radiographic Imaging System presents no new safety concerns. It will comply with the x-ray requirements of 21CFR as well as safety requirements of UL2601-1, IEC601-1 and collateral standards. Summary of Studies: Two radiologists at each of three hospitals evaluated 30 paired digital and film / screen images of representative anatomical

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

- · A Hazard Analysis
image quality.

- · A Software Development and Validation Process
- · External validations of paired sets of film / screen image and digital images by three different research hospitals to assess the diagnostic equivalence of the digital images.

areas, and found that the digital images had equivalent or better

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The text is in a sans-serif font and is blue.

Public Health Service

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

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

AUG 20 2013

Re: K982196

Trade/Device Name: GE Digital Radiographic Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: September 4. 1998 Received: September 8, 1998

Dear Dr. Kroger:

This letter corrects our substantially equivalent letter of October 6. 1998.

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 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):

510(k) Number (if known): K982/960

Device Name: Digital Radiographic Imaging System

## Indications for Use

The Digital Radiographic Imaging 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)
OR Over-The-Counter Use_

OR Over-The-Counter Use_

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