Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard medical display monitor with features like high resolution, luminance, and DICOM support. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is a monitor intended for displaying diagnostic images, not for providing therapy or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc."

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an LCD Panel, motherboard, power cable, and data cable, in addition to software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
Device Function: The R190/R191 LCD Monitor is a display device used to view digital images generated by imaging modalities like X-ray and MRI. It does not perform any tests on biological samples.
Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis." This is a function related to medical imaging, not in vitro testing.

The information provided describes a medical imaging display, which is a different category of medical device than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

R190/R191 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Product codes

PGY

Device Description

R190/R191 LCD Monitor is the display system with the resolution(1280*1024), high luminance (800cd/m2), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside.
R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time.

The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel

M150M/P38 motherboard/FR-4
R190/R191 LCD Monitor software
Power cable
Data Cable.

The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray or MRI, etc.

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

Bench testing was conducted to demonstrate the R190/R191 meets all performance standards as follows:

Measurement of the angular dependency of luminance response in horizontal, . vertical and diagonal directions
Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
Measurement of small-spot contrast ratio.
Measurement of temporal response
. Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the R190/R191 The device complies with the IEC 60601-1:2012 standard for safety and the IEC 60601-1:2012 and EN 60601-1-2:2015 standard for EMC.

Animal and clinical study
The subject of this premarket submission,R190/R191, does not require animal or clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K061303

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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510(k) Summary K183494

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	Dec 3, 2018
Submitter:	Nanjing Jusha Display Technology Co., Ltd
	Add: 8A, Block 1. Nanjing International Service Outsourcing
Mansion, No. 301, Hanzhongmen street, Nanjing, China.
Contact Person:	Zilong Liang
	Certification Manager
	Nanjing Jusha Display Technology Co., Ltd
	Tel: +86-25- 83305050
	Fax: +86-25-5878 3273
Device Trade Name:	R190 LCD Monitor,R191 LCD Monitor
Common/Usual Name:	1MP Monochrome LCD Monitor
Classification Name: Product
Code:	Display, Diagnostic Radiology 21CFR 892.2050
PGY
Predicate Device(s):	MDM 1900-1NR AND MDM 1900-1NR; K061303
Device Description:	R190/R191 LCD Monitor is the display system with the resolution
(1280*1024), high luminance (800cd/m2), and can present up to 1.07
billion colors(1024 grayscale), 1 DICOM look up table inside.
R190/R191 uses luminance stabilization mechanism to ensure
brightness stability in the product service time.

The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel

M150M/P38 motherboard/FR-4
R190/R191 LCD Monitor software
Power cable
Data Cable.

The LCD Monitor is designed, tested, and will be manufactured in
accordance with both mandatory and voluntary standards. |
| Intended Use: | 1. IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance
2. IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests |
| Intended Use: | R190/R191 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis. |
| Technology: | R190/R191 LCD Monitor is the display system with the resolution monitor (1 megapixels) with electronic capabilities for evaluation of high resolution medical images,the resolution $(1280*1024)$ , high luminance (800cd/m²), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time. |
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor complies with voluntary standards as following:

IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance
IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests
R190/R191 is substantially equivalent to MDM 1900-1NR.
R190/R191 employs the maximum resolution values same as that of MDM 1900-1NR. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
Attachment 1
The following quality assurance measures were applied to the development of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Raw materials verification |
| | Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the R190/R191 LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |

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12.1 Product Comparison

This comparison identifies the similarities and differences of the proposed R190/R191 LCD Monitor device to the legally marketed predicate CHILIN MDM 1900-1NR LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device	Proposed Device	Discussion of Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor	-
510(k) Number	K061303	K183494	K183494	-
Display Performance/Specifications
Screen technology	19" Monochrome TFT LCD Panel	19" Monochrome TFT LCD Panel	19" Monochrome TFT LCD Panel	Same
Viewing angle (H, V)	Horizontal 170°,Vertical 17 0°	Horizontal 176°,Vertical 176°	Horizontal 176°,Vertical 176°	-
Attribute
S	Predicate Device	Proposed Device	Proposed Device	Discussion of
Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor
510(k)
Number	K061303	K183494	K183494
Resolutio
n	1024 x 1280	1280*1024	1280*1024	The difference
between the two
devices is due to
the different
viewing directions
and does not affect
performance.
Display
area	376.32 (H) x
301.056(V) mm	374.7840 (H) x
299.8272(V) mm	374.7840 (H) x
299.8272(V) mm	Same
Contrast
Ratio	800:1	1000:1	1000:1	-
Response
Time	18ms	16ms	16ms	-
Scanning
frequenc
y (H; V)	75
kHz;63.4~79.78Hz	52~~76 kHz;59~~61Hz	52~76
kHz;59~61Hz	This difference
between the two
device is caused by
the different no
display area
defined by
different
manufacturers ,
nothing to do with
the display
function
Recomme
nded
Luminanc
e	1000cd/m2	800cd/m2	800cd/m2	This item is the
maximum
brightness of the
LCD panel. After
the curve is
corrected, the
difference is not
large and does not
affect the use.
Pixel
Pitch	0.294x0.294 mm	0.2928x0.2928mm	0.2928x0.2928mm	-
Backlight	LED	LED	LED	Same.
Attribute	Predicate Device	Proposed Device	Proposed Device	Discussion of
Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor
510(k)
Number	K061303	K183494	K183494
DICOM
LUT	12-bit : 4096	10-bit:1024	10-bit:1024	Both devices use
grayscale extension
technology, and the
final display effect
is not much
different, which
does not affect the
use of the product.
Luminance
calibration	Built in calibration
sensor provided	Built in calibration
sensor provided	Built in calibration
sensor provided	Same
		Video Signal Input
Input
signals	DVI standard
D-Sub	DVI-D
DisplayPort
HDMI
DVI-A	DVI-D
DisplayPort
HDMI
SOG
Input
terminational	DVI-D (dual link) x
1,
D-Sub x 1	DVI-D (dual link) x 1,
DisplayPort x 1
HDMI x1
DVI-A x 1	DVI-D (dual link) x
1, DisplayPort x 1
HDMI x1
SOG x 1	-
Display
controller	Off the shelf	Off the shelf	Off the shelf	Same
Power Related Specification
Power
Requirement	AC 100~240V	AC 100~240V	AC 100~240V	Same
Power
Consumption/Save
Mode	47W/less than 0.5W	25W/less than 0.5W	25W/less than 0.5W	-
Attributes	Predicate Device	Proposed Device	Proposed Device	Discussion of
Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor
510(k)
Number	K061303	K183494	K183494
Power
Management	DVI DMPM
DisplayPort	DVI DMPM
DisplayPort	DVI DMPM
DisplayPort	-
Miscellaneous Features/Specifications
Service
interface	RS232	USB	USB	This interface is
only used to
communicate with
the host, does not
affect the
performance of the
display.
Dimensions w/o stand
(W x H x D)	Without stand:
344mmx418mmx82.5mm	Without stand:
419mm x343mm
x71mm	Without stand:
419mm x343mm
x71mm	Different housing
design due to the
different panel size.
	With stand:
344mmx433mmx227 mm	With stand:
419mm x379mm
x198mm	With stand:
419mm x379mm
x198mm

3

4

5

6

Attributes	Predicate Device	Proposed Device	Proposed Device	Discussion of Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor
510(k)
Number	K061303	K183494	K183494
Indication for use	MDM 1900-1NR
Monitor is intended
to be used in
displaying and
viewing digital
images for diagnosis
of X-ray or MRI,
etc. by trained
medical
practitioners. The
device does not
support the display
of mammography
images for
diagnosis.	R190 LCD Monitor is
intended to be used in
displaying and
viewing digital
images for diagnosis
of X-ray or MRI, etc.
by trained medical
practitioners. The
device does not
support the display of
mammography
images for diagnosis.	R191 LCD Monitor
is intended to be
used in displaying
and viewing digital
images for
diagnosis of X-ray
or MRI, etc. by
trained medical
practitioners. The
device does not
support the display
of mammography
images for
diagnosis.	Same
Attributes	Predicate Device	Proposed Device	Proposed Device	Discussion of Differences
Product	CHILIN MDM
1900-1NR	R190 LCD Monitor	R191 LCD Monitor
510(k) Number	K061303	K183494	K183494
Applicable standard	1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)
2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.	1.IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance
2.IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests	1.IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance
2.IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests	-

7

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PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Bench testing:

Bench testing was conducted to demonstrate the R190/R191 meets all performance standards as follows:

Measurement of the angular dependency of luminance response in horizontal, . vertical and diagonal directions
Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
Measurement of small-spot contrast ratio.
Measurement of temporal response
. Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the R190/R191 The device complies with the IEC 60601-1:2012 standard for safety and the IEC 60601-1:2012 and EN 60601-1-2:2015 standard for EMC.

Animal and clinical study

The subject of this premarket submission,R190/R191, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

R190/R191 Medical Monitor is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the R190/R191 Medical Monitor does not raise any new issues of safety or effectiveness.

9

Image /page/9/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA

April 5, 2019

Re: K183494

Trade/Device Name: R190/R191 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2019 Received: January 11, 2019

Dear Zilong Liang:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general controls provisions of the Act. Although this letter refers to your products as devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

10

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

11

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183494

Device Name

R190/R191 LCD Monitor

Indications for Use (Describe)

R190/R191 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRJ, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

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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