Nio Color 2MP (MDNC-2123)

K171812 · Barco N.V. · PGY · Jul 19, 2017 · Radiology

Device Facts

• Record ID: K171812
• Device Name: Nio Color 2MP (MDNC-2123)
• Applicant: Barco N.V.
• Product Code: PGY · Radiology
• Decision Date: Jul 19, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Nio Color 2MP LED Medical Flat Panel Display System 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-2123) is a medical-grade flat panel display system; receives digital image inputs from external sources (e.g., PACS); displays images for review and analysis by trained medical practitioners in clinical settings. Device functions as a visual output interface; enables clinicians to view diagnostic images to support clinical decision-making. System is a derivative of the Nio Color 3MP (MDNC-3421) featuring a 2MP resolution IPS-TFT color LCD panel, lightweight chassis, and updated firmware. Benefits include high-resolution visualization of medical imagery for diagnostic review.

Clinical Evidence

Bench testing only. Performance validated via Product Producibility Validation Report (PPVR), environmental testing, electrical safety testing, EMC testing, and firmware testing. No clinical or animal data provided.

Technological Characteristics

IPS-TFT Color LCD panel; 2MP (1920x1080) resolution; 16:9 aspect ratio; 460 cd/m² max luminance; 1000:1 contrast ratio; 15ms response time; 1x DisplayPort input; USB 2.0 connectivity; 25W nominal power consumption. Firmware-controlled.

Indications for Use

Indicated for trained medical practitioners to display and view digital images (excluding digital mammography) for review and analysis; includes 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 3MP (MDNC-3421) (K170837)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2017

Barco NV (Healthcare Division) % Lieven De Wandel Regulatory Officer President Kennedypark 35 Kortrijk, 8500 BELGIUM

Re: K171812

Trade/Device Name: Nio Color 2MP (MDNC-2123) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 20, 2017 Received: June 22, 2017

Dear Lieven 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. 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 (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171812

Device Name Nio Color 2MP (MDNC-2123)

Indications for Use (Describe)

The Nio Color 2MP LED Medical Flat Panel Display System 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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| 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<br>person | Lieven De Wandel<br>Regulatory Affairs Officer | | | | |
| 3. Date of<br>submission | 16 June 2017 | | | | |
| 4. Device<br>information | Trade name/model: Nio Color 2MP (MDNC-2123)<br>Common name: MDNC-2123<br>Classification name: System, image processing, Radiological<br>Classification code: PGY<br>Regulation number: 892.2050 | | | | |
| 5. Predicate<br>device | Nio Color 3MP (MDNC-3421) cleared under 510(K) K170837 | | | | |
| 6. Device<br>description | The MDNC-2123 is a derivative of the MDNC-3421. The modifications are:<br>✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel<br>✓ Change in chassis housing (light-weight design)<br>✓ Change in packaging (smaller size)<br>✓ Change in electronics board<br>✓ Updated firmware | | | | |
| 7. Intended Use<br>of the Device | The Nio Color 2MP LED Medical Flat Panel Display System is intended to be used for<br>displaying and viewing digital images (excluding digital mammography) for review and<br>analysis by trained medical practitioners.<br>Note: There are no changes to the indications for use statement from that of the<br>unmodified device. | | | | |
| 8. Comparison<br>of technological<br>characteristics | Specification | MDNC-3421 | MDNC-2123 | | |
| | Screen technology | IPS-TFT Color LCD | IPS-TFT Color LCD | | |
| | Active screen size (diagonal) | 540 mm (21.3") | 598 mm (23.6") | | |
| | Active screen size (H x V) | 433 x 325 mm (17.0 x 12.8") | 521 x 293 mm (20.5 x 11.5") | | |
| | Aspect ratio (H:V) | 4:3 | 16:9 | | |
| | Resolution | 3MP (2048 x 1536) | 2MP (1920 x 1080 pixels) | | |
| | | | | | |
| | Pixel pitch | 0.2155 mm | | 0.2715 mm | |
| | Color imaging | Yes | | Yes | |
| | Gray imaging | Yes | | Yes | |
| | Viewing angle (H, V) | 176° | | 170° | |
| | Per Pixel Uniformity (PPU) | No | | No | |
| | Ambient Light Compensation<br>(ALC) | No | | No | |
| | Maximum luminance | 800 cd/m² | | 460 cd/m² | |
| | DICOM calibrated luminance<br>(ULT off) | 400 cd/m² | | 320 cd/m² | |
| | Contrast ratio (typical) | 1400:1 | | 1000:1 | |
| | Response time (Tr + Tf) | 40 ms | | 15 ms | |
| | | | | 1x DVI | |
| | Video input signals | DVID Dual Link, DisplayPort | | 1x DisplayPort | |
| | | 1 upstream (endpoint), 2 downstream | | 1 upstream (endpoint), 2 downstream | |
| | USB ports | nstream | | nstream | |
| | USB standard | 2.0 | | 2.0 | |
| | Power consumption (nominal) | 50W | | 25W | |
| | | Portrait: 378 x 528~628 x 235<br>mm | | Portrait: 560 x 412~512 x 202<br>mm | |
| | Dimensions with stand (W x H<br>x D) | Landscape: 491 x 472~572 x<br>235 mm | | Landscape: 338 x 571~624 x<br>202 mm | |
| | | Portrait: 378 x 491 x 84 mm | | Portrait: 560 x 335 x 61 mm | |
| | Dimensions w/o stand (W x H<br>x D) | Landscape: 491 x 378 x 84<br>mm | | Landscape: 335 x 560 x 61<br>mm | |
| | | | | DE WP version: 7.2 kg | |
| | Net weight with stand | 12.8 kg | | DE WH version: 5.9 kg | |
| | Indications for use | The Nio Color 3MP LED<br>Medical Flat Panel Display<br>System is intended to be used<br>for displaying and viewing<br>digital images (excluding<br>digital mammography) for<br>review and analysis by trained<br>medical practitioners.<br>The display may be used in<br>dental applications. | | The Nio Color 2MP LED<br>Medical Flat Panel Display<br>System is intended to be used<br>for displaying and viewing<br>digital images (excluding<br>digital mammography) for<br>review and analysis by trained<br>medical practitioners.<br>The display may be used in<br>dental applications. | |
| 9. Performance<br>testing | The bench tests mentioned below were performed to validate the device characteristics<br>that differ from the predicate device: | | | | |
| | Modification to device | | Test performed | | |
| Change in LCD panel | | | PPVR (Product Producibility Validation<br>Report) | | |
| | Change in chassis housing | | Environmental tests | | |

BARCO

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BARCO

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| Change in packaging | Environmental tests |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Change in electronics board | Environmental tests |
| | Electrical Safety tests |
| | EMC tests |
| Updated firmware | Firmware tests |
| 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>Animal testing has not been performed. | |
| 10. Conclusion | The Nio Color 2MP was found to be substantially equivalent to the predicate device, due<br>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<br>affect 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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