The Color Coronis 2MP-21" 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.

The MFCD 2321 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.

Device Description

Color Coronis 2MP-21" is a display system for medical viewing. It consists of 3 components: MFCD 2321 is a 21.3" color LCD display. BarcoMed 2MP2CF-e is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software. 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.

MFCD 2321 is a 21.3" color LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

AI/ML Overview

This 510(k) submission describes two medical display systems, the Color Coronis 2MP-21" and the MFCD 2321. Both are intended for displaying and viewing digital images for review by trained medical practitioners, specifically excluding primary image diagnosis in mammography.

The submission is a claim of substantial equivalence to predicate devices (Color Coronis 2MP medical flat panel display system for the Color Coronis 2MP-21", and MFCD 2320 for the MFCD 2321). This means the manufacturer is asserting that the new devices are as safe and effective as existing legally marketed devices, rather than presenting a study demonstrating new performance characteristics against specific acceptance criteria.

Therefore, the provided document does not contain information regarding traditional acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/CADe device submission would. Instead, the "proof" is the demonstration of substantial equivalence to already cleared devices.

Here's why the requested information cannot be fully provided based on the input:

No specific acceptance criteria are listed for the new devices' performance. The "acceptance criteria" here is implicitly "be substantially equivalent to the predicate device."
No new performance study focused on diagnostic accuracy or clinical outcomes was conducted. The studies would have been the original validation studies for the predicate devices.
No AI/CADe components are described. The devices are display systems.

However, I can extract the relevant information about the equivalence claim and the limited testing mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for equivalence)	Reported Device Performance (as claimed for substantial equivalence)
Color Coronis 2MP-21"
Substantially equivalent to predicate device (Color Coronis 2MP medical flat panel display system) in technical characteristics, general function, application, and intended use.	"The Barco Color Coronis 2MP-21" is substantially equivalent to the predicate device, Color Coronis 2MP medical flat panel display system. 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."
MFCD 2321
Substantially equivalent to predicate device (MFCD 2320) in technical characteristics, general function, application, and intended use. (Implied, similar to above)	"The Barco MFCD 2321 is substantially equivalent to the predicate device, MFCD 2320. 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." (Note: The provided text for MFCD 2321 specifically omits the "technical characteristics" phrase in the conclusion, but it's logically implied from the preceding discussion)
Specific Performance Parameters (for the components, compared to predicate) (e.g., resolution, color depth, QA software functionality)	Color Coronis 2MP-21":MFCD 2321 display: 1600x1200 pixels resolution, landscape/portrait mode. BarcoMed 2MP2CF-e board: 32-bit in/out LUT, 24-bit color depth (16 million colors). MediCal Pro software: automated image QA, display viewing performance maintenance/logging, QA task automation, system calibration. Comparison: Different display controller board and a different LCD panel with a "somewhat larger screen size" compared to predicate. Other components same. MFCD 2321 (standalone display): 1600x1200 pixels resolution, landscape/portrait mode. MediCal Pro software: automated image QA, maintains/logs display viewing performance, automates QA, sets up calibration. Comparison: Different LCD panel with a "somewhat larger screen size" compared to predicate.

2. Sample size used for the test set and the data provenance

This information is not applicable / not provided in a traditional sense. These submissions are for medical display systems, not devices that process image data for diagnostic findings. Therefore, there are no "test sets" of patient data or data provenance of that nature described. The testing would revolve around the technical specifications and functionality of the display and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable / not provided. As explained above, no test set requiring expert ground truth is described.

4. Adjudication method for the test set

This information is not applicable / not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable / not provided. There is no AI component in these display systems, and no MRMC study is described. The devices are for viewing images by human practitioners, not for AI-assisted interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable / not provided. These are display systems, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable / not provided.

8. The sample size for the training set

This information is not applicable / not provided. These devices do not use machine learning algorithms that require training sets.

9. How the ground truth for the training set was established

This information is not applicable / not provided.

Summary

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510(k) Summary In accordance with 21 CFR 807.92

K052352

1. Date of preparation

SEP 3 0 2005

August 24, 2005

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: Color Coronis 2MP-21" .
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: Color Coronis 2MP medical flat panel display system .
510(k) number: K040365 ●
Manufacturer: Barco NV .

6. Device description

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.

7. Intended use

"The Color Coronis 2MP-21" 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.

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8. Summary of technological characteristics

The device consists of three components:

One 2-megapixel flat panel display (MFCD 2321) .
One 24-bit display controller (BarcoMed 2MP2CF-e board) .
. MediCal Pro software

The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode.

The display controller board is an ultra-high speed board with a 32-bit in, 32-bit out lookup table and 24 bit color depth, providing 16 million colors.

The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up system calibration.

Compared to the predicate device, Color Coronis 2MP-21" has a different display controller board and the display of the Color Coronis 2MP-21" system has a different LCD panel with a somewhat larger screen size. The other components of the system 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 Color Coronis 2MP-21" is substantially equivalent to the predicate device, Color Coronis 2MP medical flat panel display system.

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 Color Coronis 2MP-21" contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.

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510(k) Summary In accordance with 21 CFR 807.92

1. Date of preparation

August 24, 2005

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: MFCD 2321 (PA)
. 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: MFCD 2320
. 510(k) number: K040158
. Manufacturer: Barco NV

6. Device description

MFCD 2321 is a 21.3" color LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

7. Intended use

The MFCD 2321 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.

8. Summary of technological characteristics

The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape or

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The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up display system calibration.

Compared to the predicate device, the MFCD 2321 display has a different LCD panel with a somewhat larger screen size.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

9. Conclusion:

The Barco MFCD 2321 is substantially equivalent to the predicate device, MFCD 2320.

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 MFCD 2321 contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortijk BELGIUM

Re: K052352 Trade/Device Name: Color Coronis 2MP-21 and MFCD 2321 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 24, 2005 Received: September 8, 2005

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, Jabeling. 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.

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.

SEP 3 0 2005

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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 premated 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 rryou dobits of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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INDICATIONS FOR USE

710(k) Number (if known): Kosz352

Device Name: Color Coronis 2MP-21"

Indications for Use:

"The Color Coronis 2MP-21″ 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 (21 CFR 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Syson

(Division Sian-Off) Division of Reproductive and Radiological Devices 510(k) Number

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INDICATIONS FOR USE

-10(k) Number (if known): 长ወ52352

Device Name: MFCD 2321

Indications for Use:

"The MFCD 2321 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

(21 CFR 801 Subpart C)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Lyman

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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).