(57 days)
The Barco MGD 521 5 MegaPixel Diagnostic Display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MGD 521 device is a diagnostic display. The Barco MGD 521 is a electronic resolution monitor with high resolution capabilities for evaluation of high medical images.
This is a medical device, a Monitor/Display, not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Displaying and viewing digital images for medical review and analysis. | The Barco MGD 521 is intended to be used in displaying and viewing digital images for medical review and analysis by trained practitioners. |
| High resolution for evaluation of medical images. | The Barco MGD 521 is an electronic resolution monitor with high resolution capabilities for evaluation of high medical images. |
2. Sample Size for Test Set and Data Provenance
Not applicable. This is a hardware display device, not an AI/ML diagnostic tool that processes a "test set" of medical images.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The device's performance is based on its technical specifications for displaying images, not on expert interpretations of data it processes.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a display monitor, not an AI system designed to assist human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a display, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The "ground truth" for a display device would primarily relate to its technical specifications (e.g., resolution, brightness, contrast, color accuracy) and its ability to accurately render images as intended by the source, rather than a clinical ground truth like pathology or outcomes data.
8. Sample Size for Training Set
Not applicable. This is a hardware device; it does not have a "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable.
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APR - 9 1998
Barco NV/Display Systems A. Manufacturer : Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Submitted By:
Ferguson Medical Consultant to Barco NV
- +32(0)56 23 32 11 Contact Information: Phone: B. FAX: +32(0)56 23 3 74
- image communication Classification System, C. Name : tube, (accessory), display, cathode ray or, medical.
Workstation, monitor, greyscale Common/usual Name: monitor/display, and others.
Barco MGD 521 5 MegaPixel Diagnostic Proprietary Name: Display
- Classification Number: 90LMD D.
- Barco NV/Display Systems, Substantial Equivalence: E. Medical Workstation Display Barco MWD 321 (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Technology, Aurora Diagnostic Workstation Aurora (K962589), ScImage, Inc., Netra Workstation System and Netra MD Software (K960911), Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Advantage Windows Review Medical Systems, GE Workstation (K960613), and others.
- The MGD 521 device is a diagnostic F . Device Description: display.
- G. Intended Use: The Barco MGD 521 device is intended to be used in displaying and viewing digital images medical review and analysis by trained for practitioners.
- H. Technological Characteristics: The Barco MGD 521 is a electronic resolution monitor with high resolution capabilities for evaluation of high medical images.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 1998
Barco NV Display Systems Frank Ferguson Official Correspondent c/o Ferguson Medical 3407 Bav Avenue Chico, CA 95973
Re:
Barco MGD 521 5 MegaPixel Diagnostic Display Dated: January 15, 1998 Received: February 11, 1998 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification i submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K980541 510(k) Number (If known):
Barco MGD 521 5 MegaPixel Diagnostic Display evice Name:
Indications For Use:
The Barco MGD 521 5 MegaPixel Diagnostic Display is intended to be used in displaying and viewing digital images 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)
Jirist C. Begtson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.