MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE

K033006 · Barco NV Barcoview · LLZ · Apr 20, 2004 · Radiology

Device Facts

• Record ID: K033006
• Device Name: MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
• Applicant: Barco NV Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Story

MIVD 1218 is an 18-inch grayscale display monitor; functions as a tool for viewing digital medical images. Operated by trained medical practitioners in clinical settings. Device receives digital image data; transforms data into high-resolution visual output for diagnostic review and analysis. Facilitates clinical decision-making by providing accurate visual representation of medical images. Benefits patient through support of timely, accurate diagnostic review by clinicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution grayscale monitor; electronic capabilities for medical image evaluation. Form factor: 18-inch display module.

Indications for Use

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

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

• MFCD 118 (K000291)

Submission Summary (Full Text)

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K033006

## APR 2 0 2004

(

## 510(K) SUMMARY

| Manufacturer: | Barco NV Barcoview<br>Theodoor Sevenslaan 106<br>8500 Kortrijk<br>Belgium |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical<br>Consultant to Barco NV |
| Contact Information: | Phone: [phone]<br>FAX: [phone] |
| Classification Name: | System, image processing |
| Common/Usual Name: | Medical flat panel grayscale display, monitor,<br>display and others |
| Proprietary Name: | MIVD 1218 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | MFCD 118 (K000291) |
| Device Description: | The MIVD 1218 is a diagnostic display |
| Intended Use: | The MIVD 1218 device is intended to be used<br>in displaying and viewing digital images for<br>review by trained medical practitioners. |
| Technological Characteristics: | The MIVD 1218 device is a high resolution<br>monitor with electronic capabilities for<br>evaluation of high resolution medical images. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, with three lines above it. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

Barco NV BarcoView c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111

Re: K033006

Trade/Device Name: MIVD 1218 18 Inch Grayscale Display Module Regulation Number: 21 CFR §892.2050 Regulation Namc: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2003 Received: January 26, 2004

Dear Mr. Ferguson:

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 either class II (Special Controls) or class III (PMA), it may be subject to 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 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
. I a legally This letter will allow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaleries and the premarket notification. The FDA inding of substantial of arrants of 5-5
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
r the could be and on and of the first of the sumbers, becad on the requira If you desire specific advice for your device on our his may be 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 Additionally, for questions on the promotion in the regulation entitled, "Misbranding
Office of Compliance at [phone]. 1979, 2017 97 Other of Compliance at [phone]. FL00, percessor.97) you may obtain. Other geceeral by reference to prematical (21 of 1 x 1 x 1 x 1 x 1 x 8 x 4 x 4 x 4 x 4 x 4 x 4 x 4 x 1 x 1 x 1 x 1 x 1 x 1 information on your responsibilities under the Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-d (11 may Manufacturers, International and Consumer i Issionw.ida.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

Page 2

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510(k) Number (If known): K033006

Device Name: MIVD 1218

Indications For Use:

The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lymm

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(Division Sign-Off)

Division of Reproductive, Abdominal, ane Padiological Devices 1550 5 11)(k) Number ______________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________