Coronis Fusion 4MP LED

K143157 · Barco N.V. · PGY · Nov 12, 2014 · Radiology

Device Facts

• Record ID: K143157
• Device Name: Coronis Fusion 4MP LED
• Applicant: Barco N.V.
• Product Code: PGY · Radiology
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Story

The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display system used by medical practitioners in clinical settings for reviewing digital medical images. The system comprises an LCD display, an optional high-resolution display controller board installed in a PACS workstation, and QA software. The device utilizes LED backlight technology to illuminate images. The integrated QA software ensures the display remains DICOM compliant. The display receives video input signals via DVI-D or DisplayPort 1.1. By providing a high-resolution, calibrated visual interface, the device assists clinicians in the accurate review and analysis of diagnostic images, supporting clinical decision-making. The system includes features like Uniform Luminance Technology (ULT), Per Pixel Uniformity (PPU), Ambient Light Compensation (ALC), Backlight Output Stabilization (BLOS), and an I-Guard sensor to maintain image quality and consistency.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), DICOM calibration, luminance uniformity, firmware validation, and environmental testing (shock/vibration/impact).

Technological Characteristics

TFT AM LCD Dual Domain IPS Pro display; 29.8" diagonal; 2560 x 1600 resolution; LED backlight; 178° viewing angle; 1000:1 contrast ratio; 20ms response time. Features: ULT, PPU, ALC, BLOS, I-Guard. Connectivity: DVI-D Dual Link, DisplayPort 1.1, USB 2.0. Power: 100-240V. Software: QA software for DICOM compliance.

Indications for Use

Indicated for trained medical practitioners for the review and analysis of digital medical images, excluding digital mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Coronis Fusion 4MP DL (MDCC-4130) (K111989)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12, 2014

Barco NV % Mr. Lieven De Wandel Regulatory Affairs Officer 35 President Kennedypark 8500 Kortriik BELGIUM

Re: K143157

Trade/Device Name: Coronis Fusion 4MP LED Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 21, 2014 Received: November 3, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert A. Ochs

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## Indications for Use

510(k) Number (if known) K143157

Device Name Coronis Fusion 4MP LED (MDCC-4230)

Indications for Use (Describe)

The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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| 510(k) Summary (in accordance with 21 CFR 807.92) | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>B-8500 Kortrijk<br>BELGIUM | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2. Contact<br>person | Lieven De Wandel<br>Regulatory Affairs Officer | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 3. Date of<br>submission | October 21, 2014 | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 4. Device<br>information | Trade name/model: Coronis Fusion 4MP LED (MDCC-4230)<br>Common name: 4MP color LCD display<br>Classification name: System, image processing, Radiological<br>Classification code: PGY<br>Regulation number: 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 5. Predicate<br>device | Coronis Fusion 4MP DL (MDCC-4130) cleared under 510(K) K111989 | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6. Device<br>description | The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display<br>system for reviewing medical images. It consists of an LCD display (MDCC-4230), an<br>optional high-resolution display controller board and QA software.<br>The display controller board is installed in a PACS workstation computer, connected to the<br>display. The QA software helps to make and keep the displays DICOM compliant.<br>The display uses LED backlight technology. | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7. Intended Use<br>of the Device | The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System is<br>intended to be used as a tool in displaying and viewing digital images (excluding digital<br>mammography) for review and analysis by trained medical practitioners. | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 8. Comparison<br>of technological<br>characteristics | Specification MDCC-4130 MDCC-4230 Screen technology TFT AM LCD Dual Domain IPS Pro TFT AM LCD Dual Domain IPS Pro Active screen size (diagonal) 756 mm (29.8") 756 mm (29.8") Active screen size (H x V) 641.28 x 400.8 mm<br>(25.2 x 15.8") 641.28 x 400.8 mm<br>(25.2 x 15.8") Aspect ratio (H:V) 16:10 16:10 Resolution 4MP (2560 x 1600) 4MP (2560 x 1600) Pixel pitch 0.2505 mm 0.2505 mm Color imaging Yes Yes Gray imaging No No | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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BARCO

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| | Viewing angle (H, V) | | | 178° | | | |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------|--------------------------------------|--|--|--|
| | Uniform Luminance Technology (ULT) | Yes | | Yes | | | |
| | Per Pixel Uniformity (PPU) | No | | Yes | | | |
| | Ambient Light Compensation (ALC) | Yes | | Yes | | | |
| | Backlight Output Stabilization (BLOS) | Yes | | Yes | | | |
| | I-Guard | Yes | | Yes | | | |
| | Maximum luminance | 950 cd/m² | | 720 cd/m² | | | |
| | DICOM calibrated luminance (ULT off) | 500 cd/m² | | 500 cd/m² | | | |
| | Contrast ratio (typical) | 1100:1 | | 1000:1 | | | |
| | Response time (Tr + Tf) | 20 ms | | 20 ms | | | |
| | Scanning frequency (H; V) | | 30-150 kHz; 15-80 Hz | 30-150 kHz; 15-80 Hz | | | |
| | Video input signals | | DVI-D Dual Link | DVI-D Dual Link /<br>DisplayPort 1.1 | | | |
| | | 1 upstream (endpoint), | | 1 upstream (endpoint), | | | |
| | USB ports | | 3 downstream | 3 downstream | | | |
| | USB standard | 1.0 | | 2.0 | | | |
| | Power requirements (nominal) | 100-240V | | 100-240V | | | |
| | Power consumption (nominal) | 135W | | 105W | | | |
| | Power save mode | Yes | | Yes | | | |
| | Net weight with stand | 28.1 kg | | 21.5 kg | | | |
| | Net weight w/o stand | 21.6 kg | | 15 kg | | | |
| | | | | | | | |
| | Modification to device | | Test performed | | | | |
| | LED backlight instead of CCFL | | DICOM calibration and Luminance<br>Uniformity tests | | | | |
| | Different platform (including firmware) | | Firmware tests | | | | |
| | Additional DisplayPort video input | | Firmware tests | | | | |
| | Uniformity correction: Per pixel uniformity<br>(vs per zone unif. on predicate device) | | Luminance Uniformity tests | | | | |
| | Other material of front filter | | lmpact test in IEC 60601-1 tests | | | | |
| | Other material for sheet metal parts | | Shock and Vibration tests in<br>Environmental test report | | | | |
| | Additional tests performed: Electrical Safety test (IEC 60601-1), EMC test (IEC 60601-1-2) | | | | | | |
| | The tests showed that the device has similar or superior characteristics compared to the<br>predicate device and did not reveal new issues of safety and performance. | | | | | | |
| | Animal or clinical testing have not been performed. | | | | | | |
| 10. Conclusion | The Coronis Fusion 4MP LED (MDCC-4230) was found to be substantially equivalent to | | | | | | |

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| the predicate device, due to the following reasons: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a) Device and predicate device have the same intended use<br>b) The technological characteristics differences from the predicate device do not affect safety or effectiveness<br>c) Bench testing showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance. |

Image /page/5/Picture/2 description: The image shows the word "BARCO" in a sans-serif font. The word is white and is set against a black background. To the right of the word is a stylized logo that appears to be a circle with a line extending from each side.