(48 days)
Not Found
No
The summary describes a medical display system and associated software for image viewing and quality assurance. There is no mention of AI, ML, or any functionality that suggests the use of such technologies for image analysis, interpretation, or decision support. The software is described as a "softcopy QA software application for local calibration and QA control," which is a standard function for medical displays and does not imply AI/ML.
No
The device is described as a display system for viewing digital images and does not appear to directly treat or diagnose a disease or condition.
No
The device is a display system for viewing medical images, not a device that makes a diagnosis. It explicitly states it "must not be used in primary image diagnosis".
No
The device description explicitly states that the system consists of a color LCD display, software, and a graphic board, indicating it is a hardware and software system, not software-only.
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 the MDNC 3120 and Nio Color 3MP are display systems intended for displaying and viewing digital images. They are used by medical practitioners to review images, not to perform tests on biological samples.
- Intended Use: The intended use is focused on image review, not on analyzing biological specimens.
- Device Description: The device components are a display, software for image optimization, and a graphic board. These are all related to image presentation, not laboratory testing.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.
"The Nio Color 3MP 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 Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
MDNC 3120: MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing. The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape or portrait mode. The MediCal QAWeb Aqent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.
Nio Color 3MP: Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). 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 3-megapixel flat panel display (MDNC 3120), One 32-bit display controller, MediCal QAWeb Agent software. The flat panel display has a resolution of 2048 x 1536 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, providing up to 64 bit color. The MediCal QAWeb Aqent software allows to set the display test patterns. calibrate the display and view additional display controller information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March, 8 2007
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: MDNC 3120
- . 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: E-2320C
- . 510(k) number: K052958
- . Manufacturer: Barco NV
6. Device description
MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.
7. Intended use
"The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.
8. Summary of technological characteristics
MAY - 2 2007
1
The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape or portrait mode.
The MediCal QAWeb Aqent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.
Compared to the predicate device, the MDNC 3120 display has a different LCD panel, other electronic and mechanical parts. The basic specifications and functions, however, 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 MDNC 3120 is substantially equivalent to the predicate device, E-2320C. 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 MDNC 3120 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
March, 8 2007
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: Nio Color 3MP
- 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 Nio 2MP
- . 510(k) number: K052958
- . Manufacturer: Barco NV
6. Device description
Nio Color 3MP is a display system for medical viewing. It consists of 3 components:
MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100)
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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 Nio Color 3MP is intended to be used in displaying and viewing digital images for review by
3
trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
8. Summary of technological characteristics
The device consists of three components:
- One 3-megapixel flat panel display (MDNC 3120) .
- . One 32-bit display controller
- MediCal QAWeb Agent software .
The flat panel display has a resolution of 2048 x 1536 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, providing up to 64 bit color.
The MediCal QAWeb Aqent software allows to set the display test patterns. calibrate the display and view additional display controller information.
Compared to the predicate device, the display from the Nio Color 3MP system has a different LCD panel, other electronic boards and other mechanical parts. The software is a new version. However, the basic specifications and functions of all the parts 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 Nio Color 3MP is substantially equivalent to the predicate device, Color Nio 2MP.
i, i.
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 Nio Color 3MP contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. The text is centered in the image.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Lieven De Wandel Official Correspondent BarcoView Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM
MAY - 2 2007
K070726 Re:
Trade/Device Name: Nio Color 3MP and MDNC 3120 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 8, 2007 Received: March 15, 2007
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.
Image /page/4/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars at the bottom of the logo, and the entire design is surrounded by a dotted border.
Protecting and Promoting Public Health
5
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.
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 marketed 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 contact the Office 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
510(k) Number (if known): K010226
Device Name: Nio Color 3MP
Indications for Use:
"The Nio Color 3MP 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 tramou mounty. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
Prescription Use _XX
(Part 21 CFR 801 Subpart D)
AND/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 Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
7
INDICATIONS FOR USE
510(k) Number (if known): K076226
Device Name: MDNC 3120
Indications for Use:
"The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.
Prescription Use XX
(Part 21 CFR 801 Subpart D)
AND/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 Chrogdon
Dinsion Sian-Off ann of Reproductive, Abdo Anlogical Devices neiki Number