(60 days)
Not Found
No
The summary describes a display system and associated hardware/software for viewing medical images, with no mention of AI or ML capabilities for image analysis or interpretation.
No.
The device is a display system for viewing medical images, not for providing therapy. It is used for displaying and viewing digital images for review by trained medical practitioners.
No
The device is a display system for medical viewing and explicitly states it "must not be used in primary image diagnosis in mammography." Its purpose is to display images for review by practitioners, not to perform the diagnosis itself.
No
The device description explicitly states it consists of a grayscale LCD display and a display controller board, which are hardware components. While it includes software, it is not solely software.
Based on the provided information, the Coronis 3MP is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Coronis 3MP Function: The Coronis 3MP is a display system intended for viewing digital medical images. It does not perform any tests on biological samples. Its purpose is to present images for review by medical practitioners.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images."
- Device Description: The description details a display, a controller board, and QA software – all components related to image presentation, not sample analysis.
Therefore, the Coronis 3MP falls under the category of a medical image display system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Product codes
90LLZ
Device Description
Coronis 3MP is a display system for medical viewing. It consists of 3 components: MDCG 3120-CB is a 20.8" grayscale LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent for a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
The device consists of three components:
- One 3-megapixel flat panel display (MDCG 3120-CB)
- One 32-bit display controller (MXRT 5100 board)
- MediCal QAWeb Agent software
The flat panel display has a resolution of 1536x2048 pixels. It can be used in landscape and portrait mode.
The MXRT 5100 display controller board is an ultra-high speed board with a 32-bit in, 32-bit out lookup table, providing up to 64 bit color.
The MediCal OAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.
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
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
510(K) SUMMARY
In accordance with 21 CFR 807.92
1. Date of preparation
June 28, 2006
SEP - 5 2006
2. Company information
BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457
3. Contact person
Lieven De Wandel Official correspondent
4. Device information
- . Trade name: Coronis 3MP
- Common name: Display system, medical image workstation, and others .
- Classification name: System, Image Processing .
- . Classification number: 21 CFR 892.2050 / Procode 90LLZ
5. Predicate device
- . Name: Coronis 2MP-21"
- 510(k) number: K052403 .
- . Manufacturer: Barco NV
6. Device description
Coronis 3MP is a display system for medical viewing. It consists of 3 components: MDCG 3120-CB is a 20.8" grayscale LCD display. MXRT 5100 is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent for a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it วntains multiple displays and display controller boards.
7. Intended use
"The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be need in primary image diagnosis in mammography.
1
8. Summary of technological characteristics
The device consists of three components:
- . One 3-megapixel flat panel display (MDCG 3120-CB)
- One 32-bit display controller (MXRT 5100 board) .
- . MediCal QAWeb Agent software
The flat panel display has a resolution of 1536x2048 pixels. It can be used in landscape and portrait mode.
The MXRT 5100 display controller board is an ultra-high speed board with a 32-bit in, 32-bit out lookup table, providing up to 64 bit color.
The MediCal OAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.
Compared to the predicate device, the display from the Coronis 3MP system has a different LCD panel, other electronic boards and other mechanical parts. The software is a new version. However, the basic specifications and functions of all the parts are the same.
The device does not come into contact with the patient. It does not control any life sustaining devices either.
9. Conclusion:
The Barco Coronis 3MP is substantially equivalent to the predicate device, Coronis 2MP-21". The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.
Any difference between both devices does not affect safety or efficacy.
The 510(k) Pre-Market Notification for the Barco Coronis 3MP contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white emblem for the Department of Health & Human Services USA. The emblem features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 5 2006
Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM
Re: K061924
Trade/Device Name: Coronis 3MP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2006 Received: July 7, 2006
Dear Mr. De Wandel:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" below that. There are three stars at the bottom of the logo. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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Page 2 -
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ___
Device Name: Coronis 3MP
Indications for Use:
"The Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Prescription Use XX
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. logenson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number