MFCD 2320

K040158 · Barco N.V. · LLZ · Apr 12, 2004 · Radiology

Device Facts

• Record ID: K040158
• Device Name: MFCD 2320
• Applicant: Barco N.V.
• Product Code: LLZ · Radiology
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MFCD 2320 Medical Flat Color Display 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

The MFCD 2320 is a high-resolution medical flat panel color display monitor. It functions as a diagnostic tool for medical practitioners to view and analyze digital medical images. The device is intended for clinical environments where high-resolution visualization of diagnostic data is required. It does not support digital mammography. The monitor provides the visual interface necessary for clinicians to interpret medical imaging studies, facilitating clinical decision-making based on the displayed digital data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution flat panel color monitor designed for medical image evaluation. Electronic capabilities for high-resolution image display.

Indications for Use

Indicated for use by trained medical practitioners for the display and review of digital medical images, excluding 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 120 (K000294)

Submission Summary (Full Text)

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KO40158

APR 1 2 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 color display, monitor,<br>display and others |
| Proprietary Name: | MFCD 2320 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | MFCD 120 (K000294) |
| Device Description: | The MFCD 2320 is a diagnostic display |
| Intended Use: | The MFCD 2320 device is intended to be used<br>in displaying and viewing digital images for<br>review by trained medical practitioners. |
| Technological Characteristics: | The MFCD 2320 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 2 2004

BARCO NV BARCOVIEW % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111

Re: K040158 Trade/Device Name: MFCD 2320 Medical Flat Color Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 10, 2004 Received: January 23, 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 10 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 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 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) 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. Brydon

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

Enclosure

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510(k) Number (If known): K040158

Device Name: MFCD 2320 Medical Flat Color Display

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ XX = (Per 21 CFR 801.109)

OR

Over-The» Counter Use ________________________________________________________________________________________________________________________________________________________

David A. Ingram
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _