Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on display characteristics and standard calibration functions, with no mention of AI/ML terms or capabilities.

Therapeutic

No
The device is a monitor intended for displaying medical images for diagnosis, not for providing therapy.

Diagnostic

Yes
The device is described as "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners," which explicitly states its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an LCD Panel, main board, Power Adapter, and Data Cable, in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs are used to examine specimens from the human body. The intended use of the JUSHA-M350G/JUSHA-M350/M350 LCD Monitor is to display and view digital images from imaging modalities like X-ray and MRI. These are images of the human body itself, not specimens taken from the body.
The device description focuses on display characteristics. The description details the resolution, luminance, grayscale, and built-in standards of the monitor, all of which relate to the visual presentation of images. It does not mention any components or processes related to analyzing biological samples.
The performance studies are related to display quality. The bench testing described focuses on metrics like luminance uniformity, contrast ratio, and temporal response, which are relevant to the performance of a medical display, not an IVD.

In summary, the JUSHA-M350G/JUSHA-M350/M350 LCD Monitor is a medical device used for displaying diagnostic images, which falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

JUSHA-M350G/JUSHA-M350/M350G/M350 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

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1536), high luminance (1000 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M350G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

21.3" Mono-TFT LCD Panel
DMX0704AR0/main board/REV1.1
JUSHA-M350G LCD Monitor software
Power Adapter
Data Cable.

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

IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray or MRI

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)

Bench testing was conducted to demonstrate the JUSHA-M350G 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 EMC testing were conducted on the JUSHA-M350G. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

The subject of this premarket submission, JUSHA-M350G, does not require animal or clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

JUSHA-M33C; K141690

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

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

February 4, 2019

Re: K183499

Trade/Device Name: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: Class II Product Code: PGY Dated: December 20, 2018 Received: December 20, 2018

Dear Zilong Liang:

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

Michael D. O'Hara

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183499

Device Name

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

Indications for Use (Describe)

JUSHA-M350G/JUSHA-M350/M350 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.

X 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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3

510(k) Summary K183499

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

Date:	December 6, 2018
Submitter:	Nanjing Jusha Display Technology Co., Ltd
Contact Person:	Add: 301, 8F Block A, No.1, Nanjing International Service
Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China
Zilong Liang
Certification Manager
Nanjing Jusha Display Technology Co., Ltd
Tel: +86-25- 83305050
Fax: +86-25- 58783273
Device Trade Name:	JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
Common/Usual Name:	3MP Monochrome LCD Monitor
Classification Name:	Display, Diagnostic Radiology 21CFR 892.2050
Product Code:	PGY
Predicate Device(s):	JUSHA-M33C; K141690
Device Description:	JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1536), high luminance (1000 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M350G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

21.3" Mono-TFT LCD Panel
DMX0704AR0/main board/REV1.1
JUSHA-M350G LCD Monitor software |
| | - Power Adapter |
| | - Data Cable. |
| | The LCD Monitor is designed, tested, and will be manufactured in
accordance with both mandatory and voluntary standards: |
| | 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010,
CAN/CSA C22.2 NO.60601-1:14, Medical equipment
medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.

IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,
CFR 47 FCC Part15 subpart B: 2017, Medical electrical
equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-M350G/JUSHA-M350/M350G/M350 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: | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the |
| | display system with the high resolution (2048*1536), high luminance |
| | (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM |
| | standard LUT. In particular, JUSHA-M350G has ambient brightness |
| | adapting, real-time DICOM automatic calibration, full-screen |
| | brightness equalization, presence induction and focusview function, |
| | with these this display can automatic adjustment according to |
| | different requirements in order to achieve the best results. |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests: |
| | The LCD Monitor complies with voluntary standards as following: |
| | 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical equipment medical electrical equipment

Part 1: General requirements for basic safety and essential
performance. |
| | 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47
FCC Part15 subpart B: 2017, Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic disturbances - |
| | Requirements and tests. |
| | |
| | JUSHA-M350G/JUSHA-M350/M350G/M350 is substantially |
| | equivalent to JUSHA-M33C. |
| | JUSHA-M350G/JUSHA-M350/M350G/M350 employs the maximum |
| | resolution values same as that of JUSHA-M33C. 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 |
| | • Testing on unit level (Module 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 |
| | JUSHA-M350G LCD Monitor to be as safe, as effective, and |
| | performance is substantially equivalent to the predicate device(s). |

4

5

6

12.1 Product Comparison

This comparison identifies the similarities and differences of the proposed JUSHA-M350G LCD Monitor device to the legally marketed predicate JUSHA-M33C LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device	Discussion of Differences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M3
50/M350G/M350
510(k) Number	K141684	/
Display Performance/Specifications
Screen
technology	21.3" Color TFT LCD Panel	21.3" Color TFT LCD Panel	Same
Viewing angle
(H, V)	Horizontal 176°;Vertical
176°	Horizontal 178°;Vertical
178 °	-
Resolution	2048 x 1536/1536x 2048	2048 x1536/1536x 2048	Same
Display area	324.864(H) x 433.152 (V)
mm	323.942(H) x 431.923 (V)
mm	-
Contrast Ratio	1400:1	1400:1	same
Scanning
frequency (H; V)	96.7kHz;60Hz	37.9~95.4kHz;60Hz	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
Recommended
Luminance	400cd/m²	450cd/m²	-
Pixel Pitch	0.2115 x 0.2115 mm	0.2109x0.2109 mm	-
Backlight	LED	LED	Same
Attributes	Predicate Device	Proposed Device	Discussion of
Differences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M3
50/M350G/M350
510(k) Number	K141684	/
Display Colors	12-bit ,68.7 billion colors	16-bit , 281.47 Trillion
colors	The
JUSHA-M350G
LCD Monitor
uses a color bit
expansion
technology to
improve image
display quality,
the image clarity
is better than the
image displayed
on the predicate
device.
Luminance
calibration	Built in calibration sensor
provided	Built in calibration sensor
provided	Same
		Video Signal Input
Input signals	DVI-D (dual link) x 1,
DisplayPort x 1	DVI-D (dual link) x 1,
DisplayPort x 1	-
Output Signal	-	DisplayPort x 1	-
Display
controller	Off the shelf	Off the shelf	Same
Power Related Specification
Power
Requirement	AC 100~~240V 50~~60Hz	DC 24V	-
Attributes	Predicate Device	Proposed Device	Discussion of
Differences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M3
50/M350G/M350
510(k) Number	K141684	/
Power
Consumption/Sa
ve Mode	65W/less than 3W	80W/less than 0.5W	The differences
caused by
different adapter
and components
used in the LCD
Monitor, the
JUSHA-M350G
has more power
consumption and
lower save mode
power
consumption.
This only shows
the power
consumption is
different,
nothing to do
with the display
function
Power	DVI DMPM	DVI DMPM	-
Management	DisplayPort 1.1a	DisplayPort 1.2a
Miscellaneous Features/Specifications
USB
Ports/standard	1 upstream (endpoint),
2 downstream/ Rev. 2.0	1 upstream (endpoint),
2 downstream/ Rev. 2.0	Same
Dimensions w/o
stand
(W x H x D)	Without stand:
376mmx505mmx98 mm
With stand:
376mmx599mmx245.5mm	Without stand:
356mm x476mm x85mm
With stand:
356mm x525mm x238mm	Different
housing design
due to the
different panel
size.
Attributes	Predicate Device	Proposed Device	Discussion of
Differences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M3
50/M350G/M350
510(k) Number	K141684	/
Indication for
use	JUSHA-M33C 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.	JUSHA-M350G/JUSHA-M3
50/M350G/M350 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
Applicable
standard	1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+COR
R.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 equipment medical
electrical equipment - Part 1:
General requirements for
basic safety and essential
performance.
2 IEC 60601-1-2 Edition
4:2014, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
disturbances - Requirements
and tests.	-

7

8

9

10

PERFORMANCE DATA:

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

Bench testing:

Bench testing was conducted to demonstrate the JUSHA-M350G 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 JUSHA-M350G The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Animal and clinical study

The subject of this premarket submission, JUSHA-M350G, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD 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. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor does not raise any new issues of safety or effectiveness.