CORONIS 2MP AND MDCG 2121 - CB

{0}------------------------------------------------ Kio/926 # 510(K) SUMMARY In accordance with 21 CFR 807,92 ### 1. Date of preparation June 28, 2006 #### 2. Company information BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457 #### 3. Contact person Lieven De Wandel Official correspondent #### 4. Device information - . Trade name: Coronis 2MP - . 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: Coronis 2MP-21" - . 510(k) number: K052403 - . Manufacturer: Barco NV #### 6. Device description Coronis 2MP is a display system for medical viewing. It consists of 3 components: MDCG 2121-CB is a 21.3" grayscale LCD display. BarcoMed Coronis PCIe is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The display system can be a single-head system or multi-head system. In the last case it ntains multiple displays and display controller boards. #### 7. Intended use "The Coronis 2MP 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. AUG 1 8 2006 {1}------------------------------------------------ ## 8. Summary of technological characteristics The device consists of three components: - . One 2-megapixel flat panel display (MDCG 2121-CB) - . One 10-bit display controller (BarcoMed Coronis PCIe board) - . MediCal QAWeb Agent software The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode. The BarcoMed Coronis PCIe display controller board is an ultra-high speed board with a 10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray. 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 display from the Coronis 2MP system has a different LCD panel, other electronic boards and other mechanical parts. The software is a new version. However, the basic specifications and functions of all the parts 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 Coronis 2MP is substantially equivalent to the predicate device, Coronis 2MP-21", 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 Coronis 2MP contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized design of three overlapping human figures. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 #### AUG ] 8 2006 Mr. Lieven De Wandel Official Correspondent Barco-Medical Imaging Systems President Kennedypark 35, B-8500 Kortrijk BELGIUM Re: K061926 Trade/Device Name: MDCG-2121-CB 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 logo. The logo is circular and contains the text "1906-2006" at the top. Below the text is the abbreviation "PA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars below the word "Centennial." Protecting and Promoting Public Health {3}------------------------------------------------ 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 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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Hodgdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): Device Name: MDCG 2121-CB Indications for Use: "The MDCG 2121-CB 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 R. Logemann (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number