DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION

K013481 · GE Medical Systems · KPR · Nov 2, 2001 · Radiology

Device Facts

• Record ID: K013481
• Device Name: DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
• Applicant: GE Medical Systems
• Product Code: KPR · Radiology
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Dual Energy and Tissue Equalization software options are intended for use in generating digital radiographic images of human anatomy, EXCEPT MAMOCRAMS.

Device Story

Software options for stationary X-ray systems; utilizes dual-energy imaging to acquire two images at different X-ray energies; generates derived images (e.g., soft tissue and bone); includes tissue equalization algorithm to enhance contrast in thick anatomical areas while maintaining contrast in primary regions of interest; intended for clinical use by healthcare professionals; output assists in diagnostic radiographic imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing options for stationary X-ray systems. Conforms to 21 CFR 1020.30, 1020.31, and IEC 601-1-4. Implements dual-energy subtraction and tissue equalization algorithms.

Indications for Use

Indicated for generating digital radiographic images of human anatomy. Contraindicated 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)

Submission Summary (Full Text)

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K013481

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

## NOV 0 2 2001

## 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).

| <b>Identification of Submitter:</b> Larry A. Kroger, Ph.D. |
|------------------------------------------------------------|
| Senior Regulatory Programs Manager |
| GE Medical Systems |
| Tel. [phone] |
| Summary prepared: 19 February, 2001 |

- Dual Energy and Tissue Equalization Software Options for Digital Identification of Product: Radiographic Systems Stationary X-ray System Classification Name: GE Medical Systems Manufacturer: 3000 N. Grandview Blvd. Waukesha. WI 53118
- Device Description: Dual Energy is a technique whereby two images are acquired at different x-ray energies and then used to create two derived images, for example soft tissue and bone.

The Tissue equalization algorithm is used to enhance the contrast in thick areas while maintaining suitable contrast in the primary area of interest.

- Dual Energy and Tissue Equalization software options are Indications for Use: intended for use in generating digital radiographic images of human anatomy, EXCEPT MAMOCRAMS.
- Dual Energy and Tissue Equalization software options are Comparison with: equivalent to the Dual Energy and Tissue substantially Equalization software options for use on the Revolution XR/d Digital Radiographic Imaging System (K012389).
- Dual Energy and Tissue Equalization software options will Conformance: conform to applicable sections of 21CFR 1020.30 and 1020.31. The software options will also conform to IEC 601-1-4.

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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

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

General Electric Medical Systems % Mr. Reiner Krumme Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

AUG 2 1 2013

Re: K013481

Trade/Device Name: Dual Energy and Tissue Equalization Software Option Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 16, 2001 Received: October 19, 2001

Dear Mr. Krumme:

This letter corrects our substantially equivalent letter of November 2, 2001.

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

NOV 0 2 2001 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Dual Energy and Tissue Equalization software options

## Indications for Use

Dual Energy and Tissue Equalization software options are intended for use in generating Dual Energy and Though Equalization sontomy. 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_

Nancyc Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013481
510(k) Number

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