(22 days)
Not Found
No
The document describes medical displays and associated software for calibration and image enhancement (SpotView, AAM). There is no mention of AI, ML, or any learning algorithms being used for image analysis, diagnosis, or any other function of the device itself or its optional software. The performance studies focus on display characteristics and compliance with standards, not on the performance of an AI/ML algorithm.
No.
The device is a medical computer display intended for displaying and viewing digital images for review and analysis, not for providing therapy.
Yes
This device is specifically described as a "medical computer display designed for general radiology imaging applications" and is used for "displaying and viewing digital images... for review and analysis by trained medical practitioners," indicating its role in diagnostic processes.
No
The device description explicitly states that the devices are "medical computer displays" and details changes to hardware components like the LCD panel, housing, stand, internal mechanics, and internal electronics boards. While it mentions optional software, the core device is a hardware display.
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 device described is a medical display intended for displaying and viewing digital images for review and analysis by medical practitioners. It is a tool for visualizing medical images, not for performing tests on biological samples.
- Intended Use: The intended use clearly states displaying and viewing digital images, which is not an IVD activity.
- Device Description: The description focuses on the technical specifications of the display and its use in radiology and dental applications. There is no mention of analyzing biological samples.
- Associated Software: While the device can be used with software for calibration and image enhancement, these are tools that support the display of images, not IVD tests.
Therefore, this device falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications.
The MDNC-3521 model can also be used in dental applications.
The devices can also be used for home reading in radiology.
The MDNC-2521 is a derivative of the MDNC-2221.
The MDNC-3521 is a derivative of the MDNC-3421.
The modified displays are effectively identical to the respective predicate devices except for the following changes:
Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology The displays can be used optionally with QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant.
The display can be used optionally with Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of interest and increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. AAM - Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
All digital images, except digital mammography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners, home reading in radiology
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)
The below performance bench tests are performed and corresponding results reported for the modified devices MDNC-2521 and MDNC-3521 in comparison to the already cleared device MDNC-3421 as per the Physical Laboratory Testing instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022:
• Spatial resolution – MTF
• Pixel defects, Artifacts
• Temporal Response
• Maximum and Minimum Luminance
• Luminance response, Conformance to DICOM GSDF
• Angular Dependency of Luminance
• Luminance uniformity
• Reflection coefficient - Display Reflectance incl. Specular, Diffuse & Haze coefficients
• Veiling glare or small-spot contrast
• Color tracking
The tests showed that the modified devices MDNC-2521 and MDNC-3521 have similar characteristics compared to already cleared device MDNC-3421 and did not reveal new issues of safety and performance.
Additionally, the modified devices MDNC-2521 and MDNC-3521 are compliant to EMC and Safety standards.
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk. W-VL 8500 BELGIUM
March 21, 2023
Re: K230520
Trade/Device Name: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: February 27, 2023 Received: February 27, 2023
Dear Ms. Vandecandelaere:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230520
Device Name Nio Color 2MP (MDNC-2521) Nio Color 3MP (MDNC-3521)
Indications for Use (Describe)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.
| 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) | K230520 | ||
|---|---|---|---|
| 1. Company | Barco N.V. | ||
| Healthcare Division | |||
| 35 President Kennedypark | |||
| B-8500 Kortrijk | |||
| BELGIUM | |||
| 2. Contact person | Julie Vandecandelaere | ||
| Regulatory Affairs Officer | |||
| Tel: +32 (0)56 26 13 19 | |||
| julie.vandecandelaere@barco.com | |||
| 3. Date of submission | 27 February 2023 | ||
| 4. Device information | Trade name/model: Nio Color 2MP (MDNC-2521) | ||
| Nio Color 3MP (MDNC-3521) | |||
| Common name: MDNC-2521 | |||
| MDNC-3521 | |||
| Classification name: System, image processing, Radiological | |||
| Classification code: PGY | |||
| Device classification: Class 2 | |||
| Regulation number: 892.2050 | |||
| Regulation name: Medical Image Management and Processing System | |||
| 5. Predicate device | MDNC-2521: Nio Color 2MP (MDNC-2221) cleared under 510(K) K133663 | ||
| Common name: MDNC-2221 | |||
| Classification name: System, image processing, Radiological | |||
| Classification code: LLZ | |||
| Device classification: Class 2 | |||
| Regulation number: 892.2050 | |||
| Regulation name: Medical Image Management and Processing System |
MDNC-3521: Nio Color 3MP (MDNC-3421) cleared under 510(k) K170837
Common name: MDNC-3421
Classification name: System, image processing, Radiological
Classification code: PGY | | |
| Device classification: | Class 2 | | |
| Regulation number: | 892.2050 | | |
| Regulation name: | Medical Image Management and Processing System | | |
| 6. Device description | Both the Nio Color 2MP (MDNC-2521) and the Nio Color 3MP (MDNC-3521) are medical computer displays designed for general radiology imaging applications.
The MDNC-3521 model can also be used in dental applications.
The devices can also be used for home reading in radiology.
The MDNC-2521 is a derivative of the MDNC-2221.
The MDNC-3521 is a derivative of the MDNC-3421.
The modified displays are effectively identical to the respective predicate devices except for the following changes:
Updated LCD panel with same resolution and dimensions compared to the respective predicate devices New housing, display stand and internal mechanics, with similar functionality and design principle compared to the respective predicate devices Updated internal electronics boards, with similar functionality and design principle compared to the respective predicate devices Updated firmware, with similar functionality and design principle compared to the respective predicate devices New packaging, with similar functionality and design principle compared to the respective predicate devices or any other Barco diagnostic display Rephrasing of the intended usage environment, because of the evolution towards more home reading in radiology Small update in the intended user description The modified device has the following similarities compared to the unmodified device: The same intended use The same operating principle The same fundamental technology The displays can be used optionally with QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant.
The display can be used optionally with Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of interest and increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. AAM - Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the high brightness of the diagnostic applications. | | |
| 7. Intended Use of
the Device | These applications are addressed by the general term 'Intuitive Workflow Tools'.
The integration of the Intuitive Workflow Tools with the displays have been de-risked,
verified and validated to ensure that they do not affect the safety and effectiveness of
the displays.
The display can be marketed with or without the Barco MXRT display controller boards.
The display controller board is installed in a PACS workstation computer, connected to
the display.
MDNC-2521: The display is intended to be used for displaying and viewing digital images
(excluding digital mammography) for review and analysis by trained medical
practitioners. | | |
| | MDNC-3521: The display is intended to be used for displaying and viewing digital images
(excluding digital mammography) for review and analysis by trained medical
practitioners. The display may be used in dental applications.
Note: There are no changes to the indications for use statement from that of the
unmodified device. | | |
| 8. Comparison of
technological
characteristics | Item | Predicate Device
(K133663) | Device for which listing is
sought |
| | Device name | Nio Color 2MP (MDNC-2221) | Nio Color 2MP (MDNC-2521) |
| | Screen technology | IPS-Pro | IPS-SFT Color LCD |
| | Active screen size
(diagonal) | 540 mm (21.3") | 541 mm (21.3") |
| | Active screen size
(HxV) | 432 x 324 mm (17.0 x 12.8") | 433 x 325 mm (17.1 x 12.8") |
| | Aspect ratio (H:V) | 4:3 | 4:3 |
| | Resolution | 2MP (1600 x 1200 pixels) | 2MP (1600 x 1200 pixels) |
| | Color imaging | Yes | Yes |
| | Gray imaging | Yes | Yes |
| | Bit depth | 30 bit | 30 bit |
| | Viewing angle (H, V) | 178° | 178° |
| | Uniformity Correction | ULT | ULT |
| | SteadyColor Calibration | No | Yes (in MXRT Display
Controller), when used as a
system with MXRT Display
Controller & QAWeb
Enterprise |
| | Ambient Light
Compensation (ALC) | Yes, reading room selection | Yes, reading room selection |
| | Ambient Light Sensor | Yes | Yes |
| | Front sensor | Yes | Yes |
| | Maximum luminance
(panel typical) | 800 cd/m² | 1000 cd/m² |
| DICOM calibrated
luminance | 500 cd/m² | 600 Cd/m² | |
| Contrast ratio (panel
typical) | 1400:1 | 2000:1 | |
| Response time ((Tr +
Tf)/2) (typical) | 10 ms | 12 ms[*] (gray-to-gray
average) | |
| Housing color | RAL 9003 / RAL 9004 | Black (RAL 9004) / White
(RAL 9003) | |
| Video input signals | 1x DVI
1x DisplayPort | 2x DisplayPort 1.4 | |
| USB ports | 1x USB 2.0 upstream
(endpoint)
2x USB 2.0 downstream | 2x USB-B 2.0 upstream
(endpoint)
5x USB-A 2.0 downstream
(of which 1 charge port) | |
| Power rating | 24 VDC, 3.75 A | 24 VDC, 4 A | |
| Power consumption | 50 W (nominal)