(85 days)
Not Found
No
The summary describes a medical display device and does not mention any AI or ML capabilities. The "image processing" mention is likely referring to standard display processing, not AI-driven analysis.
No.
The device is a display for viewing medical images and does not interact with the patient or medical condition to provide therapy.
No
The device is described as a display tool for viewing digital images, not for performing diagnostic analysis itself. The diagnostic function is performed by trained medical practitioners review and analysis.
No
The device description explicitly states it is a "digital image display designed for use in strong magnetic environments," indicating it is a hardware device (a display).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a display function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a digital image display.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a display tool for viewing existing images, which is a different function.
N/A
Intended Use / Indications for Use
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 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.
Product codes
LLZ
Device Description
The MFCD 118i device is a digital image display designed for use in strong magnetic environments
Mentions image processing
System, image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners. The device is suitable for use in the MRI environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
APR 0 3 2002
510(K) SUMMARY
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 ________________________________________________________________________________________________________________________________________________________