CORONIS COLOR 2MP AND MDCC 2121

K061928 · Barcoview · LLZ · Sep 5, 2006 · Radiology

Device Facts

• Record ID: K061928
• Device Name: CORONIS COLOR 2MP AND MDCC 2121
• Applicant: Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Device Story

MDCC 2121 is a 21.3-inch color LCD display system for medical image viewing. Device operates in clinical environments; used by trained medical practitioners to review digital images. System includes MediCal QAWeb Agent software to optimize display for DICOM-compliant viewing; allows calibration, test pattern display, and controller information access. Device does not contact patients; does not control life-sustaining equipment. Healthcare providers use output for clinical review; not intended for primary mammography diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

21.3-inch color LCD flat panel display; 1600x1200 pixel resolution; supports landscape or portrait orientation. Includes MediCal QAWeb Agent software for DICOM-compliant calibration and display function management. Non-contact device.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review. Contraindicated for primary image diagnosis in 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

• MFGD 2621 (K052403)

Submission Summary (Full Text)

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# 510(K) SUMMARY

In accordance with 21 CFR 807.92

# 1. Date of preparation

June 28, 2006

2061928

SEP - 5 2006

# 2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. [phone] Fax [phone]

#### 3. Contact person

Lieven De Wandel Official correspondent

#### 4. Device information

- . Trade name: MDCC 2121
- . Common name: Display system, medical image workstation, and others
- Classification name: System, Image Processing .
- . Classification number: 21 CFR 892.2050 / Procode 90LLZ

# 5. Predicate device

- . Name: MFGD 2621
- . 510(k) number: K052403
- . Manufacturer: Barco NV

# 6. Device description

MDCC 2121 is a 21.3" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

#### 7. Intended use

"The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

# 8. Summary of technological characteristics

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The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape or portrait mode.

The MediCal QAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.

Compared to the predicate device, the MDCC 2121 display has a different LCD panel, other electronic and mechanical parts. The basic specifications and functions, however, are the same.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

#### 9. Conclusion:

The Barco MDCC 2121 is substantially equivalent to the predicate device, MFGD 2621. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco MDCC 2121 contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three heads or faces, with wavy lines below the figures.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 5 2006

Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM

Re: K061928

Trade/Device Name: MDCC 2121 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2006 Received: July 7, 2006

#### Dear Mr. De Wandel:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo. There are four stars at the very bottom of the logo.

Protecting and Promoting Public Health

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Page 2 -

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.

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 predicated 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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/industry/support/index.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

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# INDICATIONS FOR USE

ρ(k) Number (if known): K061928

Device Name: MDCC 2121

Indications for Use:

*The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Prescription Use XX

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seemann

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number