Nio Color 2MP (MDNC-2123)

• K Number: K171812
• Device Name: Nio Color 2MP (MDNC-2123)
• Manufacturer: Barco NV
• Date Cleared: 2017-07-19 ( 30 days)
• Product Code: PGY
• Regulation Number: 892.2050

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 Description

The MDNC-2123 is a derivative of the MDNC-3421. The modifications are: ✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel ✓ Change in chassis housing (light-weight design) ✓ Change in packaging (smaller size) ✓ Change in electronics board ✓ Updated firmware

Predicate Devices

K170837

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a medical display system and its modifications, focusing on hardware and firmware updates. There is no mention of AI, ML, or related concepts like training/test sets for algorithmic performance.

Therapeutic

No

The device is a medical display system intended for viewing and analyzing digital images, which supports diagnostic processes but does not directly administer therapy or provide therapeutic effects to a patient.

Diagnostic

No
The device is described as a display system for viewing digital images for review and analysis, not for performing diagnostic analysis itself. It facilitates diagnosis by providing a viewing platform.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions changes to hardware components such as the LCD panel, chassis housing, and electronics board, in addition to updated firmware. This indicates it is a hardware device with associated software (firmware), not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "displaying and viewing digital images... for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
• Device Description: The description focuses on the physical components and modifications of a display system. It doesn't mention any components or processes related to analyzing biological samples.
• Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
  • Reagents or assays
  • Analysis of biological specimens (blood, urine, tissue, etc.)
  • Measurement of analytes
  • Diagnostic results derived from laboratory testing

The device is a medical display system used for viewing images generated by other medical devices (like X-ray machines, CT scanners, etc.). While it's a medical device, it falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

PGY

Device Description

The MDNC-2123 is a derivative of the MDNC-3421. The modifications are:
✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel
✓ Change in chassis housing (light-weight design)
✓ Change in packaging (smaller size)
✓ Change in electronics board
✓ Updated firmware

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital images

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)

The bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device:

Modification to device: Change in LCD panel
Test performed: PPVR (Product Producibility Validation Report)

Modification to device: Change in chassis housing
Test performed: Environmental tests

Modification to device: Change in packaging
Test performed: Environmental tests

Modification to device: Change in electronics board
Test performed: Environmental tests
Test performed: Electrical Safety tests
Test performed: EMC tests

Modification to device: Updated firmware
Test performed: Firmware tests

The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K170837

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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

Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

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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)
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)
1. Company	Barco N.V.
Healthcare Division
35 President Kennedypark
B-8500 Kortrijk
BELGIUM
2. Contact
person	Lieven De Wandel
Regulatory Affairs Officer
3. Date of
submission	16 June 2017
4. Device
information	Trade name/model: Nio Color 2MP (MDNC-2123)
Common name: MDNC-2123
Classification name: System, image processing, Radiological
Classification code: PGY
Regulation number: 892.2050
5. Predicate
device	Nio Color 3MP (MDNC-3421) cleared under 510(K) K170837
6. Device
description	The MDNC-2123 is a derivative of the MDNC-3421. The modifications are:
✓ Change in LCD panel: INX 2MP panel instead of PSD 3MP panel
✓ Change in chassis housing (light-weight design)
✓ Change in packaging (smaller size)
✓ Change in electronics board
✓ Updated firmware
7. Intended Use
of the Device	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.
Note: There are no changes to the indications for use statement from that of the
unmodified device.
8. Comparison
of technological
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
(ALC)	No		No
	Maximum luminance	800 cd/m²		460 cd/m²
	DICOM calibrated luminance
(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
mm		Portrait: 560 x 412~512 x 202
mm
	Dimensions with stand (W x H
x D)	Landscape: 491 x 472~572 x
235 mm		Landscape: 338 x 571~624 x
202 mm
		Portrait: 378 x 491 x 84 mm		Portrait: 560 x 335 x 61 mm
	Dimensions w/o stand (W x H
x D)	Landscape: 491 x 378 x 84
mm		Landscape: 335 x 560 x 61
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
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.		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.
9. Performance
testing	The bench tests mentioned below were performed to validate the device characteristics
that differ from the predicate device:
	Modification to device		Test performed
Change in LCD panel			PPVR (Product Producibility Validation
Report)
	Change in chassis housing		Environmental tests

BARCO

4

BARCO

5

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
device and did not reveal new issues of safety and performance.
Animal testing has not been performed.
10. Conclusion	The Nio Color 2MP was found to be substantially equivalent to the predicate device, due
to the following reasons:
a) Device and predicate device have the same intended use
b) The technological characteristics differences from the predicate device do not
affect safety or effectiveness
c) Bench testing showed that the device has similar characteristics compared to the
predicate device and did not reveal new issues of safety and performance.

Image /page/5/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The "O" in "BARCO" has a small, stylized design element attached to its right side, resembling a small circle with a line extending from it.