Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

K230520 · Barco N.V. · PGY · Mar 21, 2023 · Radiology

Device Facts

• Record ID: K230520
• Device Name: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
• Applicant: Barco N.V.
• Product Code: PGY · Radiology
• Decision Date: Mar 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

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.

Device Story

Nio Color 2MP (MDNC-2521) and 3MP (MDNC-3521) are medical-grade color LCD displays for general radiology and dental imaging. Used in clinical settings or home reading environments by trained medical practitioners. Displays receive digital image inputs from PACS workstations via DisplayPort. Features include RapidFrame (medical overdrive algorithm) for improved temporal response, ambient light sensors, and front sensors for calibration. Optional software includes QAWeb Enterprise for DICOM compliance and Intuitive Workflow Tools (SpotView, AAM) for image enhancement (luminance/contrast adjustment, region-of-interest focusing). Output is a high-resolution visual representation of medical images, aiding clinicians in diagnostic review and analysis.

Clinical Evidence

Bench testing only. Performance evaluated against FDA guidance for display devices (2022). Metrics included spatial resolution (MTF), pixel defects, temporal response, luminance (max/min, response, uniformity, angular dependency), reflection coefficients, veiling glare, and color tracking. Compliance with EMC and safety standards confirmed.

Technological Characteristics

IPS-SFT Color LCD panels; 2MP (1600x1200) or 3MP (2048x1536) resolution; 30-bit bit depth; LED backlight; VESA 100mm mounting; DisplayPort 1.4 connectivity; 24 VDC power. Includes ambient light and front sensors. Software-driven calibration (QAWeb) and image enhancement (Intuitive Workflow Tools).

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images (excluding digital mammography) for review and analysis. MDNC-3521 is also indicated for dental applications.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Nio Color 2MP (MDNC-2221) (K133663)
• Nio Color 3MP (MDNC-3421) (K170837)

Reference Devices

• QAWeb Enterprise (D332294)
• Intuitive Workflow Tools (K191845)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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| 510(k) Summary (in accordance with 21 CFR 807.92) | K230520 | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>B-8500 Kortrijk<br>BELGIUM | | |
| 2. Contact person | Julie Vandecandelaere<br>Regulatory Affairs Officer<br>Tel: [phone]<br>[e-mail] | | |
| 3. Date of submission | 27 February 2023 | | |
| 4. Device information | Trade name/model: Nio Color 2MP (MDNC-2521)<br>Nio Color 3MP (MDNC-3521)<br>Common name: MDNC-2521<br>MDNC-3521<br>Classification name: System, image processing, Radiological<br>Classification code: PGY<br>Device classification: Class 2<br>Regulation number: 892.2050<br>Regulation name: Medical Image Management and Processing System | | |
| 5. Predicate device | MDNC-2521: Nio Color 2MP (MDNC-2221) cleared under 510(K) K133663<br>Common name: MDNC-2221<br>Classification name: System, image processing, Radiological<br>Classification code: LLZ<br>Device classification: Class 2<br>Regulation number: 892.2050<br>Regulation name: Medical Image Management and Processing System<br><br>MDNC-3521: Nio Color 3MP (MDNC-3421) cleared under 510(k) K170837<br>Common name: MDNC-3421<br>Classification name: System, image processing, Radiological<br>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.<br>The MDNC-3521 model can also be used in dental applications.<br>The devices can also be used for home reading in radiology.<br><br>The MDNC-2521 is a derivative of the MDNC-2221.<br>The MDNC-3521 is a derivative of the MDNC-3421.<br><br>The modified displays are effectively identical to the respective predicate devices except for the following changes:<br>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.<br><br>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<br>the Device | These applications are addressed by the general term 'Intuitive Workflow Tools'.<br>The integration of the Intuitive Workflow Tools with the displays have been de-risked,<br>verified and validated to ensure that they do not affect the safety and effectiveness of<br>the displays.<br>The display can be marketed with or without the Barco MXRT display controller boards.<br>The display controller board is installed in a PACS workstation computer, connected to<br>the display.<br>MDNC-2521: The display is intended to be used for displaying and viewing digital images<br>(excluding digital mammography) for review and analysis by trained medical<br>practitioners. | | |
| | MDNC-3521: The display is intended to be used for displaying and viewing digital images<br>(excluding digital mammography) for review and analysis by trained medical<br>practitioners. The display may be used in dental applications.<br>Note: There are no changes to the indications for use statement from that of the<br>unmodified device. | | |
| 8. Comparison of<br>technological<br>characteristics | Item | Predicate Device<br>(K133663) | Device for which listing is<br>sought |
| | Device name | Nio Color 2MP (MDNC-2221) | Nio Color 2MP (MDNC-2521) |
| | Screen technology | IPS-Pro | IPS-SFT Color LCD |
| | Active screen size<br>(diagonal) | 540 mm (21.3") | 541 mm (21.3") |
| | Active screen size<br>(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)…