← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K020059 # MFCD 118I (K020059) _Barco N.V. · LLZ · Apr 3, 2002 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K020059 ## Device Facts - **Applicant:** Barco N.V. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Apr 3, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The MFCD 118i Medical Flat Color Display is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners. The device is suitable for use in the MRI environment. ## Device Story MFCD 118i is a digital flat panel display designed for operation within strong magnetic environments, specifically MRI suites. It functions as a tool for medical practitioners to view and analyze digital medical images. The device utilizes materials compatible with high-strength magnetic fields to ensure operational integrity in the MRI room. It serves as a visual interface for clinicians, facilitating the review of diagnostic data. The device does not perform automated image processing or analysis; it acts as a display peripheral for existing imaging systems. ## Clinical Evidence Bench testing only. ## Technological Characteristics Flat panel display; designed for use in strong magnetic environments; utilizes MRI-compatible materials; digital input interface. ## Regulatory 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 - Barco NV Display Systems MFCD 118 Medical Flat Color Display ([K000291](/device/K000291.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 0 3 2002 ## 510(K) SUMMARY K020059 Manufacturer: Submitted By: Contact Information: Classification Name: Common/Usual Name: Classification Number: Substantial Equivalence: Proprietary Name: Device Description: Intended Use: Barco NV Display Systems Theodoor Sevenslaan 106 8500 Kortriik Belgium Ferguson Medical Consultant to Barco NV Phone: +32(0) 56 23 32 11 FAX: +32(0) 56 23 3 74 System, image processing In-room MRI display, IMRI, flat panel for MRI applications, and others MFCD 118i 21 CFR 892.2050/Procode 90LLZ Barco NV Display Systems MFCD 118 Medical Flat Color Display (K000291) The MFCD 118i device is a digital image display designed for use in strong magnetic environments The Barco MFCD 118i device is intended to be used as a tool in displaying and viewing digital image for review and analysis by trained medical practitioners. The device is suitable for use in the MRI environment The MFCD 118i device incorporates materials Technological Characteristics: that are compatible for use in strong magnetic environments {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## APR 0 3 2002 Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K020059 Trade/Device Name: MFCD 118i Flat panel display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 21, 2001 Received: January 8, 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 10 mmerce 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 your 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): KU20059 Device Name: MFCD 118i Indications For Use: The MFCD 118i Medical Flat Color Display is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners. The device is suitable for use in the MRI environment. PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) David L. Stevenson Prescription Use __ ్ల (Per 21 CFR 801.109) OR Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K020059](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K020059) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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