(9 days)
Not Found
No
The document describes a medical display system and its components, focusing on image display and quality assurance for DICOM compliance. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a medical display system for viewing images and is not intended to treat or prevent disease.
No
The device is a medical display system, which serves as a tool for viewing and analyzing digital images. While it is used by medical practitioners for review and analysis, it does not itself perform a diagnostic function but rather presents information for a human to diagnose.
No
The device description explicitly states it consists of an LCD display, an optional display controller board, and QA software. This includes hardware components (display and controller board) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a function related to medical imaging, not the analysis of biological samples (like blood, urine, or tissue) which is the core of IVD devices.
- Device Description: The device is a display system. While it's used in a medical context (reviewing medical images), it doesn't perform any tests or analyses on biological specimens.
- Lack of IVD Characteristics: The description doesn't mention any components or functions related to collecting, preparing, or analyzing biological samples. There's no mention of reagents, assays, or any other elements typically associated with IVD devices.
In summary, this device is a medical imaging display, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
PGY
Device Description
The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display system for reviewing medical images. It consists of an LCD display (MDCC-4230), an optional high-resolution display controller board and QA software. The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant. The display uses LED backlight technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
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
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.
Additional tests performed: Electrical Safety test (IEC 60601-1), EMC test (IEC 60601-1-2)
Animal or clinical testing have not been performed.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary (in accordance with 21 CFR 807.92) | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Company | Barco N.V. | |||||||||||||||||||||||||||
| Healthcare Division | ||||||||||||||||||||||||||||
| 35 President Kennedypark | ||||||||||||||||||||||||||||
| B-8500 Kortrijk | ||||||||||||||||||||||||||||
| BELGIUM | ||||||||||||||||||||||||||||
| 2. Contact | ||||||||||||||||||||||||||||
| person | Lieven De Wandel | |||||||||||||||||||||||||||
| Regulatory Affairs Officer | ||||||||||||||||||||||||||||
| 3. Date of | ||||||||||||||||||||||||||||
| submission | October 21, 2014 | |||||||||||||||||||||||||||
| 4. Device | ||||||||||||||||||||||||||||
| information | Trade name/model: Coronis Fusion 4MP LED (MDCC-4230) | |||||||||||||||||||||||||||
| Common name: 4MP color LCD display | ||||||||||||||||||||||||||||
| Classification name: System, image processing, Radiological | ||||||||||||||||||||||||||||
| Classification code: PGY | ||||||||||||||||||||||||||||
| Regulation number: 892.2050 | ||||||||||||||||||||||||||||
| 5. Predicate | ||||||||||||||||||||||||||||
| device | Coronis Fusion 4MP DL (MDCC-4130) cleared under 510(K) K111989 | |||||||||||||||||||||||||||
| 6. Device | ||||||||||||||||||||||||||||
| description | The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display | |||||||||||||||||||||||||||
| system for reviewing medical images. It consists of an LCD display (MDCC-4230), an | ||||||||||||||||||||||||||||
| optional high-resolution display controller board and QA software. | ||||||||||||||||||||||||||||
| The display controller board is installed in a PACS workstation computer, connected to the | ||||||||||||||||||||||||||||
| display. The QA software helps to make and keep the displays DICOM compliant. | ||||||||||||||||||||||||||||
| The display uses LED backlight technology. | ||||||||||||||||||||||||||||
| 7. Intended Use | ||||||||||||||||||||||||||||
| of the Device | 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. | ||||||||||||||||||||||||||||
| 8. Comparison | ||||||||||||||||||||||||||||
| of technological | ||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| (25.2 x 15.8") 641.28 x 400.8 mm | ||||||||||||||||||||||||||||
| (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 |
Image /page/3/Picture/2 description: The image shows the text "Page 1 of 3". This text likely indicates the page number of a document. The document has at least 3 pages. The text is written in a simple, sans-serif font.
BARCO
4
| 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 / | |||||
| 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 | ||||||
| Uniformity tests | |||||||
| Different platform (including firmware) | Firmware tests | ||||||
| Additional DisplayPort video input | Firmware tests | ||||||
| Uniformity correction: Per pixel uniformity | |||||||
| (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 | ||||||
| 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 | |||||||
| 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 |
Image /page/4/Picture/2 description: The image shows the word "BARCO" in white letters against a black background. The letters are bold and sans-serif. The "O" in BARCO has a unique design, with a circle and two short lines extending from either side.
5
| the predicate device, due to the following reasons: |
|---|
| a) Device and predicate device have the same intended use |
| b) The technological characteristics differences from the predicate device do not affect safety or effectiveness |
| 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.