(62 days)
None
No
The document describes a medical display system and does not mention AI, ML, or related concepts.
No
The device is a display system for medical images, not a tool for directly treating or diagnosing patients. Its function is to visualize data for review by practitioners, not to perform a therapeutic action.
No
The device is a display system, not a diagnostic device itself. It displays images for review and analysis by medical practitioners, but it does not perform the diagnosis. Its predicate device also indicates it is a display system, not a diagnostic one.
No
The device description explicitly states it is a "digital image display system" and "consists of components to provide high resolution visualization of digital images," indicating it includes hardware (the display panel and associated components).
Based on the provided information, the Barco Coronis 3MP Medical Flat Panel Display System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "displaying and viewing digital images for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples outside the body.
- Device Description: The description reinforces that it's a "digital image display system" for "high resolution visualization of digital images."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device's function is solely to display images, which are the output of other medical imaging modalities (like X-ray, CT, MRI, etc.).
N/A
Intended Use / Indications for Use
The Barco Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
Product codes
90LLZ
Device Description
The Coronis 3MP device is a digital image display system.
The Barco Coronis 3MP device consists of components to provide high resolution visualization of digital images.
Mentions image processing
Not Found
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
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)
Barco NV Display Systems MeDis 5MP2 Dual-Head Medical Diagnostic Display System (K001753)
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
Ko 13922
510(K) SUMMARY
:
JAN 2 8 2002
| Manufacturer: | Barco NV Display Systems
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical
Consultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical image
workstation, image monitor/display, and others |
| Proprietary Name: | Barco Coronis 3MP Medical Flat Panel Display
System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems MeDis 5MP2 Dual-
Head Medical Diagnostic Display System
(K001753) |
| Device Description: | The Coronis 3MP device is a digital image
display system |
| Intended Use: | The Barco Coronis 3MP Medical Flat Panel
Display System is intended to be used in
displaying and viewing digital images for
review by trained medical practitioners. |
| Technological Characteristics: | The Barco Coronis 3MP device consists of
components to provide high resolution
visualization of digital images. |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, arranged in a layered formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K013922 Trade/Device Name: Coronis 3MP Medical Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 15, 2001 Received: November 27, 2001
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 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): Ko / 3927
Device Name: Coronis 3MP Medical Flat Panel Display System
Indications For Use:
The Coronis 3MP Medical Flat Panel Display System 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)
David A. Sygnor
(Division Sign-Off)
(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012922
Prescription Use _ ్ల (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________