BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY

K033859 · Barco NV Barcoview · LLZ · Jun 2, 2004 · Radiology

Device Facts

• Record ID: K033859
• Device Name: BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY
• Applicant: Barco NV Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.

Device Story

The Barco MGD 521M is a 5-megapixel high-resolution diagnostic display system. It functions as a monitor for the evaluation of high-resolution digital medical images. The device is intended for use by trained medical practitioners in clinical settings to review and analyze images generated by digital mammography systems. By providing high-resolution visualization, it assists clinicians in the diagnostic review process, facilitating the interpretation of mammographic data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution 5-megapixel diagnostic monitor with electronic capabilities for image processing and display.

Indications for Use

Indicated for use by trained medical practitioners for the display and analysis of digital images, specifically for use with digital mammography systems meeting manufacturer-specified criteria.

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 NV Display Systems MGD 521 5 Megapixel Diagnostic Display (K980541)

Submission Summary (Full Text)

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

K033859

medical

image

. JUN - 2 2004

## 510(K) SUMMARY

- Manufacturer: Barco NV Barcoview Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Ferguson Medical Submitted By: Consultant to Barco NV

Phone: [phone] Contact Information: FAX: [phone]

System, image processing Classification Name:

Common/Usual Name:

Proprietary Name:

Classification Number:

Substantial Equivalence:

Device Description:

Intended Use:

21 CFR 892.2050/Procode 90LLZ

Barco MGD 521M

Image

Barco NV Display Systems MGD 521 5 Megapixel Diagnostic Display (K980541)

workstation, image monitor/display, and others

display system,

The MGD 521M device is a digital image display

The Barco MGD 521M device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system

## The Barco MGD 521M is a high resolution Technological Characteristics: with electronic capabilities monitor for evaluation of high resolution digital images.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2004

Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111

Re: K033859 Trade/Device Name: MGD 521M Digital Mammography Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 16, 2004 Received: May 20, 2004

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your we your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the 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). and Oosmetic Free (120) the the device, subject to the general controls provisions of the Act. The I ou may, there or ovisions 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 (PMA), 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 that I Drivel 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.

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

Page 2

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

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

Enclosure

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

510(k) Number (If known): K033859

Device Name: MGD 521M

Indications For Use:

The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ XX ... (Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________

David R. Legram

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number