COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM

K040365 · Barco N.V. · LLZ · Apr 28, 2004 · Radiology

Device Facts

• Record ID: K040365
• Device Name: COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
• Applicant: Barco N.V.
• Product Code: LLZ · Radiology
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Story

Color Coronis 2MP is a high-resolution digital flat panel display system. It receives digital image data from medical imaging systems (e.g., PACS) and renders them for visualization. Used in clinical environments by trained medical practitioners for review and analysis of diagnostic images. The device functions as a visual interface, allowing clinicians to interpret medical imagery to support clinical decision-making. It does not perform automated image analysis or diagnostic processing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Medical flat panel grayscale display system; high-resolution visualization; 21 CFR 892.2050; Product Code 90 LLZ.

Indications for Use

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

• Coronis 3MP Medical Flat Panel Display System (K013922)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 4 2004

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

Re: K040365

Trade/Device Name: Color Coronis 2MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2004 Received: February 13, 2004

Dear Mr. Ferguson:

This letter corrects our substantially equivalent letter of April 28, 2004, regarding a typographical error. The word "Color" was omitted from the trade name and has since been corrected.

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, Dr to 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

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Page 2 - Mr. Ferguson

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 marketed predicate device results in a classification for your device and thus, primits 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 [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 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,

David R. Ingram

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): K040365

Device Name: Coronis 2MP Medical Flat Panel Display System

Indications For Use:

The Coronis 2MP Medical Flat Panel Display System is intended to be used 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 A. Sgouris

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040365

Prescription Use _ XX (Per 21 CFR 801.109)

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OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________

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APR 2 8 2004

## 510(K) SUMMARY

K640365

Ferguson Medical

Consultant to Barco NV

Phone: [phone]

FAX: [phone]

System, image processing

Manufacturer:

Barco NV Barcoview Theodoor Sevenslaan 106 8500 Kortrijk Belgium

Submitted By:

Contact Information:

Classification Name:

Common/Usual Name:

Proprietary Name:

Classification Number:

Substantial Equivalence:

Device Description:

Intended Use:

Technological Characteristics:

Medical flat panel grayscale display, monitor, display and others

Color Coronis 2MP

21 CFR 892.2050/Procode 90ШZ

Coronis 3MP Medical Flat Panel Display System (K013922)

Color Coronis 2MP is a digital image display system

The Color Coronis 2MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners

The Barcoview Color Coronis 2MP device consists of components to provide high resolution visualization of digital images