SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY

K043122 · Siemens AG · LLZ · Feb 9, 2005 · Radiology

Device Facts

• Record ID: K043122
• Device Name: SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY
• Applicant: Siemens AG
• Product Code: LLZ · Radiology
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.

Device Story

The SMD 21500 / DSB-2103-D-5MP is a high-resolution grayscale flat panel display. It receives digital image data from medical imaging systems and renders it for visual review by trained medical practitioners. Used in clinical settings, the device facilitates the diagnostic evaluation of high-resolution medical images, with specific design optimization for digital mammography. By providing high-fidelity visualization, it supports clinicians in making informed diagnostic decisions.

Clinical Evidence

Bench testing only.

Technological Characteristics

High-resolution grayscale flat panel display; 5-megapixel resolution; designed for medical imaging evaluation. Connectivity via standard display interfaces. No specific materials or software algorithm details provided.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images, specifically for digital mammography applications.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Barco Coronis 5MP HD (K041508)

Submission Summary (Full Text)

{0}------------------------------------------------

K04322

## FEB - 9 2005 510(k) Summary

| Date of Application: | November 1, 2004 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Siemens AG<br>A&D SE DT - Display Technologies<br>84 Siemensallee<br>Karlsruhe, Germany 76187 |
| Contact Information: | George Scott<br>Marketing Manager, U.S.<br>Siemens Display Technologies<br>Ph: 303-604-6760<br>Fax: [phone]<br>Email: [e-mail] |
| Classification Name: | System, Image Processing |
| Common/Usual Name: | Image Display Device, Medical Imaging |
| Proprietary Name/Model: | SMD 21500 or DSB-2103-D-5MP - 5M Pixel<br>Grayscale Flat Panel Display |
| Device Ordering Codes: | 6GF6201-4Cxxx (where xxx represents<br>specific customer version) |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco Coronis 5MP HD (K041508) |
| Device Description: | The SMD 21500 / DSB-2103-D-5MP is a<br>grayscale diagnostic medical display |
| Intended Use: | The SMD 21500 / DSB-2103-D-5MP device is<br>intended to be used in displaying and viewing<br>digital images for review by trained medical<br>practitioners. It is especially designed for<br>digital mammography applications. |
| Technological Characteristics: | The SMD 21500 / DSB-2103-D-5MP device is<br>a high-resolution display with electronic<br>capabilities for evaluation of high-resolution<br>medical images.<br>(See separate comparison chart to predicate<br>device) |

:

{1}------------------------------------------------

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2005

Siemens AG % Mr. George Scott Marketing Manager Siemens Energy & Automation, Inc. Power Control Division 515 Courtney Way, Suite A LAFAYETTE CO 80026

Re: K043122 Trade/Device Name: SMD 21500 / DSB-2103-D-5MP 5M Pixel Grayscale Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 18, 2005 Received: January 18, 2005

Dear Mr. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your corned 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 the enorolours) to teening time Medical Device Amendments, or to devices that have been May 20, 1770, the charactering 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 do not require approvince of the Act. The general controls provisions of the Act. The Act de not, subject to the general 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 n your as the to be subject to such additional controls. Existing major regulations affecting your Apploval), It they of Subject 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 I rease of advisor 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 I caraf statues and regularing, 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) (21 CFR Part 807), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will and will be region mading of substantial equivalence of your device to a legally premaired notification: "Thesults 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 Part 801), please If you desire specific at not 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 Also, prease note the regaration on your responsibilities under the Act from the 807.77). Tou may oouall carees, International and Consumer Assistance at its toll-free number (800) DIVISION of Shian Hamanavia or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

{3}------------------------------------------------

## Statement of Indications for Use

Ko43122 510(k) Number:

Device Name:

Indications for Use:

SMD 21500 / DSB-2103-D-5MP — 5M Pixel Grayscale Flat Panel Display

The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.

*Prescription Use*

David B. Lonsman

(Division Sign-Off) Productive, Sign-Off)
Division of Reproductive, Abdominal, 5 100 Radiological Devices 5 10(k) Number