Nio Fusion 12MP (MDNC-12130)
Device Facts
| Record ID | K203106 |
|---|---|
| Device Name | Nio Fusion 12MP (MDNC-12130) |
| Applicant | Barco N.V. |
| Product Code | PGY · Radiology |
| Decision Date | Nov 10, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
Indications for Use
The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Device Story
Nio Fusion 12MP (MDNC-12130) is a 30.9-inch medical-grade LCD display for PACS and breast imaging. It accepts digital video input signals and renders high-resolution (4200x2800) images for diagnostic review by radiologists. The device features an integrated LED backlight, internal sensors, and controllers that continuously monitor, stabilize, and calibrate luminance to ensure DICOM GSDF conformance. SoftGlow task and wall lights are included for ambient reading room illumination. The display is operated by trained medical practitioners in clinical environments. By providing a stable, high-resolution, and calibrated visual environment, the device assists clinicians in the accurate interpretation of complex medical images, such as breast tomosynthesis, potentially improving diagnostic outcomes.
Clinical Evidence
Bench testing only. No clinical or animal data provided. Performance testing included spatial resolution (MTF), pixel defects, temporal response, luminance (max/min, response, uniformity, stability), DICOM GSDF conformance, angular dependency, spatial noise (NPS), reflection coefficients, veiling glare, and color/gray tracking. The device also met EMC and safety standards.
Technological Characteristics
30.9" a-Si TFT active matrix LCD with LED backlight; 4200x2800 resolution; 1200 Cd/m² max luminance; 1500:1 contrast ratio; 60Hz refresh rate; 2x DisplayPort 1.2 inputs. Includes integrated front sensor for luminance stabilization and ambient light sensor. Software-controlled calibration via external QAWeb quality control software. Integrated power supply. SoftGlow task/wall lighting.
Indications for Use
Indicated for trained medical practitioners for the review, analysis, and diagnosis of digital images, including standard and multiframe digital mammography and breast tomosynthesis.
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 5.8MP (MDNC-6121) (K170476)
Submission Summary (Full Text)
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November 10, 2020
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Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk. W-VL 8500 BELGIUM
Re: K203106
Trade/Device Name: Nio Fusion 12MP (MDNC-12130) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: October 8, 2020 Received: October 15, 2020
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K203106
Device Name Nio Fusion 12 MP (MDNC-12130)
Indications for Use (Describe)
The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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BARCO
| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: +32 (0)56 26 13 19<br>julie.vandecandelaere@barco.com |
| 3. Date of submission | 08 October 2020 |
| 4. Device information | Trade name/model: Nio Fusion 12MP (MDNC-12130)<br>Common name: MDNC-12130<br>Classification name: System, image processing, Radiological<br>Classification code: PGY<br>Regulation number: 892.2050 |
| 5. Predicate device | Nio Color 5.8MP (MDNC-6121) cleared under 510(K) K170476. |
| 6. Device description | The MDNC-12130 (Nio Fusion 12MP) is a medical computer display designed for both<br>PACS and breast imaging applications.<br>It consists of a 30.9" 12 mega-pixel (4200x2800 resolution) LCD panel with integrated<br>LED backlight.<br>The panel is integrated into the display housing body with an internal mechanics chassis<br>structure, that also integrates the electronics, sensors and power supply. The display<br>module is supported by a display stand.<br>Internal sensors and controllers measure, control and stabilize the device.<br>SoftGlow Lights are integrated as an ancillary function for user comfort and can be lit to<br>illuminate the desk and to create some ambient lighting in the reading room.<br><br>The 31" 12MP (4200x2800 resolution) MDNC-12130 display can be compared to a dual-<br>head, 2 x 21″ 5.8 MP (2100x2800 resolution) MDNC-6121 display system.<br><br>The MDNC-12130 is a derivative of the MDNC-6121.<br>The modified display is effectively identical to the predicate device except for the<br>following changes:<br>31" 12 mega-pixel (4200x2800 resolution) LCD panel, compared to 2 x 21inch<br>5.8 MP LCD panel of a dual-head MDNC-6121 display system New housing, display stand and internal mechanics, with similar functionality and<br>design principle compared to MDNC-6121 or any other Barco diagnostic display |
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| ✓ Change in electronics board, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display; including: | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| ✓ Integration of the power supply adaptor into the device, compared to an external power adapter for MDNC-6121 | | | |
| ✓ Updated firmware, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display | | | |
| ✓ Change in packaging, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display | | | |
| ✓ Addition of SoftGlow Task Light and Wall Light ancillary function for user comfort | | | |
| 7. Intended Use of<br>the Device | The display is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.<br><br>Note: There are no changes to the indications for use statement from that of the unmodified device. | | |
| 8. Comparison of<br>technological<br>characteristics | Item | Predicate Device<br>(K170476) | Device for which listing is<br>sought |
| | Device name | Nio Color 5.8MP (MDNC-6121) | Nio Fusion 12MP (MDNC-12130) |
| | Display Technology | | |
| | | a-Si TFT active matrix LCD<br>with LED backlight | a-Si TFT active matrix LCD with<br>LED backlight |
| | Screen size | | |
| | Active screen size<br>(diagonal) | 541 mm (21.3") | 784 mm (30.9") |
| | Active screen size<br>(HxV) | 324.45 x 432.6 mm (12.77" x<br>17") | 653 x 435 mm (25.7 x 17.1") |
| | Aspect ratio (H: V) | 3:4 for each display in portrait<br>mode, 3:2 overall for dual<br>head system | 3:2 |
| | Resolution | 5.8 MP (2100 x 2800 pixels) | Native 12MP (4200 x 2800<br>pixels)<br>Configurable to 2 x 5.8MP (2100<br>x 2800 pixels) |
| | Optical characteristics | | |
| | Maximum<br>luminance (panel<br>typical) | 1000 Cd/m² | 1200 Cd/m² |
| DICOM calibrated<br>luminance | 600 Cd/m² | 600 Cd/m² | |
| Contrast ratio<br>(panel typical) | 1400:1 | 1500:1 | |
| Frame rate and refresh rate | | | |
| Frame rate | 60 Hz (60 frames per second) | 60 Hz (60 frames per second) | |
| Response time<br>((Tr + Tf)/2)<br>(typical)<br>Gray-to-gray | 12.5 ms | 10 ms | |
| Pixel array, pitch, subpixel pattern, pixel aperture ratio | | | |
| Pixel array | 0.1545 x 0.1545 mm RGB pixel | 0.1554 x 0.1554 mm RGB pixel | |
| Pixel pitch | 0.1545 mm | 0.1554 mm | |
| DPI (dots per<br>inch) | 164 | 164 | |
| Subpixel pattern | 0.0515 x 0.1554 mm x 3<br>(RGB) | 0.0518 x 0.1554 mm x 3 (RGB) | |
| Pixel aperture<br>ratio | 53.6% | 56.5% | |
| Display Interface | | | |
| Video input<br>signals | DVI-D Dual Link (2x)<br>DisplayPort (2x) | 2 x DisplayPort 1.2 | |
| Ambient light sensing | | | |
| Ambient Light<br>Sensor | Yes | Yes | |
| Luminance calibration tools | | | |
| Front sensor | Yes | Yes | |
| Luminance<br>calibration and<br>stabilization | Integrated Front sensor with<br>luminance stabilization<br>firmware | Integrated Front sensor with<br>luminance stabilization firmware | |
| | QAWeb quality control<br>software (external) | QAWeb quality control software (external) | |
| Quality-control procedures | | | |
| QA software | QAWeb | QAWeb | |
| 9. Performance<br>testing | The technological characteristics discussed above show that the device MDNC-12130 has similar technological characteristics as the predicate device MDNC-6121 and do not reveal new issues of safety and performance. | | |
| | The below performance bench tests are performed and corresponding results reported for the modified device MDNC-12130 in comparison to the predicate device MDNC-6121, as | | |
| | per the instructions in "Guidance for Industry and FDA Staff: Display Devices for<br>Diagnostic Radiology", issued on October 2, 2017: | | |
| | Spatial resolution – MTF Pixel defects, Artifacts Temporal Response Maximum and Minimum Luminance, Luminance response Conformance to DICOM GSDF Angular Dependency of Luminance Luminance uniformity Stability of Luminance and Chromacity over Time and Operating Temperature Spatial Noise – NPS Reflection coefficient - Display Reflectance with Specular, Diffuse & Haze coefficients Veiling glare or small-spot contrast Color tracking, Gray tracking | | |
| | The tests showed that the device has similar characteristics compared to the predicate<br>device and did not reveal new issues of safety and performance.<br>Additionally, the modified device MDNC-12130 is compliant to EMC and Safety standards. | | |
| | No animal testing or clinical testing has been performed. | | |
| 10. Conclusion | The Nio Fusion 12MP (MDNC-12130) was found to be substantially equivalent to the<br>predicate device MDNC-6121, due to the following reasons:<br>a) Device and predicate device have the same intended use<br>b) The technological characteristics differences from the predicate device do not affect<br>safety or effectiveness<br>c) Bench testing showed that the device has similar characteristics compared to the<br>predicate device and did not reveal new issues of safety and performance. | | |
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