(32 days)
Not Found
No
The document describes a medical display system and its components, focusing on hardware (display, controller board) and quality assurance software. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is a display system for medical images, intended for review by medical practitioners, and does not directly treat or diagnose a disease or condition.
No
The device is described as a display system for displaying and viewing digital images, not for performing the diagnostic analysis itself. It explicitly states it "must not be used in primary image diagnosis in mammography."
No
The device description explicitly states it consists of a display system with hardware components (LCD display and display controller board) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a display system used for displaying and viewing digital images. It does not perform any tests on biological samples.
- Intended Use: The intended use is for reviewing digital images by trained medical practitioners, specifically excluding primary image diagnosis in mammography. This is a display and viewing function, not a diagnostic test performed on a sample.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic. It is a medical device used for image display and review.
N/A
Intended Use / 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.
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.
Product codes
90LLZ
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.
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.
MFCD 2321 is a 21.3" color LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.
The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape or
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.
Mentions image processing
System, Image Processing
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 (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
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
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.
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.
1
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.
2
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
3
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.
4
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
5
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
6
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
7
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