MEDICAL ADMINISTRATOR

{0}------------------------------------------------ # 510(K) SUMMARY # K020073 ه | Manufacturer: | Barco NV Display Systems<br>Theodoor Sevenslaan 106<br>8500 Kortrijk<br>Belgium | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | Ferguson Medical<br>Consultant to Barco NV | | Contact Information: | Phone: +32(0) 56 23 32 11<br>FAX: +32(0) 56 23 3 74 | | Classification Name: | System, image processing | | Common/Usual Name: | Image quality management system, hospital-<br>wide image quality management system,<br>client-server QA management system, and<br>others | | Proprietary Name: | MediCal Administrator | | Classification Number: | 21 CFR 892.2050/Procode 90LLZ | | Substantial Equivalence: | Barco NV Display Systems MediCal Display<br>Conformity and Consistency Software<br>(K982690) | | Device Description: | The MediCal Administrator device is a digital<br>image quality management system | | Intended Use: | The Barco MediCal Administrator device is<br>intended to be used as a tool for trained<br>medical practitioners to manage total image<br>softcopy quality from a central location | | Technological Characteristics: | The MediCal Administrator device is a hospital-<br>wide system that tracks the consistency of<br>individual displays and keeps the data in a<br>central database | {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 1 2 2002 Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K020073 Trade/Device Name: MediCal Administrator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: April 20, 2002 Received: April 25, 2002 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. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.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 {3}------------------------------------------------ . . 510(k) Number (If known): Device Name: MediCal Administrator Indications For Use: The MediCal Administrator device is intended to be used as a tool for trained medical practitioners to manage total image softcopy quality from a central location. ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Seymour (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Prescription Use __ XX (Per 21 CFR 801.109) OR Over-The- Counter Use __________