(114 days)
The Barco MeDis 2MP1NT Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MeDis 2MP1NT Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained practitioners.
The MeDis 2MP1NT device is a digital image display system.
The Barco MeDis 2MP1NT device consists of components to provide high resolution visualization of digital images.
The provided text is a 510(k) summary and FDA clearance letter for the Barco MeDis 2MP1NT Medical Diagnostic Display System. This document describes a medical display system, not an AI-powered diagnostic device, and therefore does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI.
The information provided pertains to the regulatory clearance of a medical device (a display system) and focuses on its substantial equivalence to a predicate device, its intended use, and its technological characteristics. It does not include:
- A table of acceptance criteria and reported device performance (in terms of AI metrics).
- Any details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set, as these are relevant to studies evaluating diagnostic performance, typically for algorithms or new diagnostic methods.
- Information on MRMC comparative effectiveness studies with AI assistance.
- Details about standalone algorithm performance.
- The type or method of establishing ground truth for training or test sets.
- Training set sample size or how its ground truth was established.
In summary, the provided document is not about an AI device and does not offer the specific data points requested for such a system.
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510(K) SUMMARY
ん 022773
| Manufacturer: | Barco NV BarcoviewTheodoor Sevenslaan 1068500 KortrijkBelgium |
|---|---|
| Submitted By: | Ferguson MedicalConsultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical imageworkstation, image monitor/display, and others |
| Proprietary Name: | Barco MeDis 2MP1NT Medical DiagnosticDisplay System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems MeDis 2MP2 Dual-Head Medical Diagnostic Display System(K001747) |
| Device Description: | The MeDis 2MP1NT device is a digital imagedisplay system |
| Intended Use: | The Barco MeDis 2MP1NT Medical DiagnosticDisplay System is intended to be used indisplaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The Barco MeDis 2MP1NT device consists ofcomponents to provide high resolutionvisualization of digital images. |
in the
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.
Public Health Service
od and Drug Administra 9200 Corporate Boulevard Rockville MD 20850
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038
Re: K022773
Trade/Device Name: MeDis 2MP1NT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and
communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 30, 2002 Received: November 4, 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.
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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) 594-459 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-465 |
| Other | (301) 594-469 |
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. Snogdin
Nancy C. Progdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (If known): Kolz
Device Name: MeDis 2MP1NT
Indications For Use:
. . .
The MeDis 2MP1NT Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained practitioners.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Legron
Prescription Use XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
§ 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).