(14 days)
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 like deep learning, algorithms for image analysis beyond display, or performance metrics typically associated with AI/ML models (AUC, sensitivity, specificity). The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The device is a display system for viewing digital images and does not provide therapy or treatment.
No
The device is intended strictly for displaying and viewing digital images for review by trained medical practitioners, explicitly stating it "must not be used in primary image diagnosis." This indicates it is a display device, not a diagnostic one.
No
The device description explicitly lists hardware components: a grayscale LCD display and a display controller board.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images for review by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The device is a "display system for medical viewing" consisting of a display, a controller board, and software. This aligns with a medical image display system, not an IVD device which would typically involve reagents, instruments for analyzing samples, etc.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic results based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is to present existing digital images for visual review.
N/A
Intended Use / Indications for Use
The 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 MFGD 2621 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 2MP-21" is a display system for medical viewing. It consists of 3 components: MFGD 2621 is a 21.3" grayscale LCD display. BarcoMed Coronis 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.
MFGD 2621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.
Mentions image processing
Yes
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
KD52463
510(k) Summary In accordance with 21 CFR 807.92
1. Date of preparation
SEP 1 5 2005
August 29, 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: 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: Coronis 2MP
- 510(k) number: K023322 .
- . Manufacturer: Barco NV
6. Device description
Coronis 2MP-21" is a display system for medical viewing. It consists of 3 components:
MFGD 2621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy OA software.
The display system can be a single-head system or multi-head system. In the last case it ontains multiple displays and display controller boards.
7. Intended use
The 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 (MFGD 2621) .
- One 10-bit display controller board (BarcoMed Coronis) .
- . 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 10-bit in, 10-bit out look-up table, providing 1024 simultaneous levels of gray.
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, the display of the 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 Coronis 2MP-21" is substantially equivalent to the predicate device, Coronis 2MP, 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 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 29, 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: MFGD 2621 .
- 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: MFGD 2320 .
- 510(k) number: K033004 .
- Manufacturer: Barco NV .
6. Device description
MFGD 2621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.
7. Intended use
'he MFGD 2621 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 an The Ticalcul Tro votther Press QA tasks and sets up display system calibration.
Compared to the predicate device, the MFGD 2621 display has a different LCD panel with 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 MFGD 2621 is substantially equivalent to the predicate device, MFGD 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 MFGD 2621 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lieven De Wandel Official Correspondent BarcoView - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM
. Re: K052403 Trade/Device Name: Coronis 2MP-21" and MFGD 2621 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 29, 2005 Received: September 1, 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, 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.
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 1 6 2005
5
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of Saccament - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of our 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 Also, please note the regulation childed, "hisornation on your responsibilities under the Act from the 180 807.97). You may outain other general missional 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
2 Enclosures
6
INDICATIONS FOR USE
0(k) Number (if known): ______________________________________________________________________________________________________________________________________________________
Device Name: Coronis 2MP-21"
Indications for Use:
Indications for USC:
The Coronis 2MP-21" is intended to be used in displaying aigital images for review. The Coronis 2MP-21" is Intended to be used in ulsplaying and Transman in Submit Submiss in the mammography.
Prescription Use XX (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
AND/OR
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)
Dancyll Braden
(Division Sign Division of Reproduc and Radiological Devil 510(k) Number
7
INDICATIONS FOR USE
10(k) Number (if known): צבעצבע בכבע ב
Device Name: MFGD 2621
Indications for Use:
Indications for USC.
The MFGD 2621 is intended to be used in displaying and viewing digital images for review by The MFGD 2621 is intended to be used in ulsplaying and viewing alguined by the may image diagnosis in mammography.
Prescription Use XX_
(Part 21 CFR 801 Subpart D)
AAD/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)
Nancy C. Inosdon
(Division Sla Division of Reproductive. and Radiological Device 5 10(k) Numbe