BARCO MWD 321 MEDICAL WORKSTATION DISPLAY

K972701 · Barco NV Display Systems · LMD · Jan 2, 1998 · Radiology

Device Facts

• Record ID: K972701
• Device Name: BARCO MWD 321 MEDICAL WORKSTATION DISPLAY
• Applicant: Barco NV Display Systems
• Product Code: LMD · Radiology
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The Barco MWD 321 device is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

Device Story

The Barco MWD 321 is a high-resolution medical workstation display. It receives digital image data from medical imaging systems and renders these images for visual inspection. Used in clinical environments, it allows trained medical practitioners to review and analyze high-resolution medical images to support clinical decision-making. The device functions as a peripheral monitor for medical imaging workstations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution monitor with electronic capabilities for medical image evaluation. Designed for integration into medical imaging workstations.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for clinical review and analysis.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999)
• Sony Trinitron Color Video Monitor PVM-1343MD (K885042)
• Aurora Diagnostic Workstation (K962589)
• ScImage Netra MD Software (K960911)
• Applicare Medical B.V. Radworks Medical Imaging Software (K962699)
• Accuimage, Inc. Processor (K961023)
• GE Medical Image Display Systems GE Advantage Windows Review Workstation (K960613)

Submission Summary (Full Text)

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## 510(k) SUMMARY

## JAN - 2 1998

| A. | Manufacturer: | Barco NV/Display Systems<br>Theodoor Sevenslaan 106<br>8500 Kortrijk<br>Belgium |
|----|---------------|---------------------------------------------------------------------------------|
|----|---------------|---------------------------------------------------------------------------------|

Ferguson Medical Submitted By: Consultant to Barco NV

- [phone] Phone: B. Contact Information: [phone] FAX:
- C. System, immage communication Classification Name: (accessory), cathode tube, or, display, ray medical.

Common/usual Name: Workstation, image workstation, and others.

Barco MWD 321 Medical Workstation Proprietary Name: Display

- Classification Number: D. 90LMD or 74DXJ
- E. Substantial Equivalence: Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Medical Systems Division, Sony Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Technology, Aurora Diagnostic Workstation Aurora Inc., Netra Workstation System (K962589), ScImage, and Netra MD Software (K960911), Applicare Medical B.V., Radworks Medical Imaging Software Imaging Accuimage, Inc., Accuimage, (K962699), and Inc. (K961023), Processor GE Medical Image Display Systems, GE Advantage Windows Review Workstation (K960613), and others.
- F. The MWD 321 device is a workstation Device Description: display.
- G. Intended Use: The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
- H. Technological Characteristics: The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images.

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 2 1998

Frank Ferguson Official Correspondent Consultant for Barco NV Display Systems 3407 Bay Avenue Chico, California 95973

Re: K972701

> Barco MWD 321 Medical Workstation Display Dated: November 12, 1997 Received: November 19, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Mr. Ferguson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (If known):

Barco MWD 321 Medical Workstation Display Qevice Name:

Índications For Use:

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The Barco MWD 321 Medical Workstation is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Lichard L. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K972701

**Prescription Use** √
(Per 21 CFR 801.109)

Over-The-Counter Use _