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.

Device Description

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1560), 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor. This device is a diagnostic display monitor, not an AI/ML-driven medical device. Therefore, the information requested in the prompt regarding acceptance criteria and study data for AI/ML performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (JUSHA-M33C) based on technical characteristics, performance specifications (luminance, resolution, contrast, etc.), applicable standards (electrical safety, EMC), and intended use.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this type of device are primarily compliance with recognized standards and demonstration of comparable performance to a predicate device. The performance data is presented as a comparison table between the proposed device and the predicate.

Attributes	Predicate Device (JUSHA-M33C)	Proposed Device (JUSHA-M350G/JUSHA-M350/M350G/M350)	Discussion of (non-significant) Differences
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 x 1536/1536x 2048	Same
Display Area	324.864(H) x 433.152 (V) mm	323.942(H) x 431.923 (V) mm	- (Minor difference attributed to different manufacturing definitions)
Contrast Ratio	1400:1	1400:1	Same
Scanning Frequency (H; V)	96.7kHz; 60Hz	37.9~95.4kHz; 60Hz	Difference noted as due to different no-display area definition, not affecting display function.
Recommended Luminance	400cd/m²	450cd/m²	-
Pixel Pitch	0.2115 x 0.2115 mm	0.2109x0.2109 mm	-
Backlight	LED	LED	Same
Display Colors	12-bit, 68.7 billion colors	16-bit, 281.47 Trillion colors	Proposed device uses color bit expansion technology for improved image clarity. This is presented as an improvement, not a failure.
Luminance Calibration	Built-in calibration sensor provided	Built-in calibration sensor provided	Same
Video Signal Input	DVI-D (dual link) x 1, DisplayPort x 1	DVI-D (dual link) x 1, DisplayPort x 1	-
Output Signal	-	DisplayPort x 1	- (Proposed device has an additional output signal)
Display Controller	Off the shelf	Off the shelf	Same
Power Related Specification
Power Requirement	AC 100~~240V 50~~60Hz	DC 24V	-
Power Consumption/Save Mode	65W/less than 3W	80W/less than 0.5W	Differences attributed to different adapter and components, not affecting display function. Lower save mode power consumption is an improvement.
Power Management	DVI DMPM, DisplayPort 1.1a	DVI DMPM, 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 mmWith stand: 376mmx599mmx245.5mm	Without stand: 356mm x476mm x85mmWith stand: 356mm x525mm x238mm	Different housing design due to different panel size.
Indication for Use	Same as proposed device	Intended for displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. Does not support display of mammography images for diagnosis.	Same
Applicable Standard	IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007), IEC 60601-1-2 Ed. 3:2007	IEC 60601-1:2012, IEC 60601-1-2 Ed. 4:2014	Newer versions of standards are met.

Bench testing was conducted to demonstrate the proposed device meets certain performance standards, including:

Measurement of the angular dependency of luminance response (horizontal, vertical, diagonal)
Measurement of the luminance non-uniformity characteristics (per TG18 guideline)
Measurement of the chromaticity non-uniformity characteristics (per TG18 guideline)
Measurement of small-spot contrast ratio
Measurement of temporal response
Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC) testing also showed compliance with IEC 60601-1 and IEC 60601-1-2.

2. Sample size used for the test set and the data provenance:

This is a hardware device (LCD monitor), not an AI/ML diagnostic algorithm. Therefore, there are no "test sets" of patient data in the context of diagnostic accuracy. The "testing" refers to bench testing of the monitor's technical specifications and compliance with electrical/EMC standards. The document does not specify a "sample size" for these bench tests, as it typically involves testing a representative number of units or prototypes to ensure compliance. Data provenance is not applicable in the context of patient data here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth and expert adjudication are relevant for diagnostic algorithms assessing medical images, not for a display monitor.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a display device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for a monitor is its adherence to specified optical and electrical performance parameters, as measured by calibrated equipment, and its compliance with relevant industry standards (e.g., DICOM, IEC).

8. The sample size for the training set:

Not applicable. There is no AI/ML model being trained.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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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

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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

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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)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 ServiceOutsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 ChinaZilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +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 inaccordance with both mandatory and voluntary standards:
	1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipmentmedical electrical equipment - Part 1: Generalrequirements 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 electricalequipment - Part 1-2: General requirements for basicsafety 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 fordiagnosis of X-ray or MRI, etc. by trained medical practitioners. Thedevice does not support the display of mammography images fordiagnosis.
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 SubstantialEquivalence:	Summary of Non-Clinical Tests:
	The LCD Monitor complies with voluntary standards as following:
	1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medical equipment medical electrical equipment- Part 1: General requirements for basic safety and essentialperformance.
	2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47FCC Part15 subpart B: 2017, Medical electrical equipment - Part1-2: General requirements for basic safety and essentialperformance - 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).

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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-M350/M350G/M350
510(k) Number	K141684	/
Display Performance/Specifications
Screentechnology	21.3" Color TFT LCD Panel	21.3" Color TFT LCD Panel	Same
Viewing angle(H, V)	Horizontal 176°;Vertical176°	Horizontal 178°;Vertical178 °	-
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
Scanningfrequency (H; V)	96.7kHz;60Hz	37.9~95.4kHz;60Hz	This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers,nothing to dowith the displayfunction
RecommendedLuminance	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 ofDifferences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M350/M350G/M350
510(k) Number	K141684	/
Display Colors	12-bit ,68.7 billion colors	16-bit , 281.47 Trillioncolors	TheJUSHA-M350GLCD Monitoruses a color bitexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice.
Luminancecalibration	Built in calibration sensorprovided	Built in calibration sensorprovided	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	-
Displaycontroller	Off the shelf	Off the shelf	Same
Power Related Specification
PowerRequirement	AC 100~~240V 50~~60Hz	DC 24V	-
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M350/M350G/M350
510(k) Number	K141684	/
PowerConsumption/Save Mode	65W/less than 3W	80W/less than 0.5W	The differencescaused bydifferent adapterand componentsused in the LCDMonitor, theJUSHA-M350Ghas more powerconsumption andlower save modepowerconsumption.This only showsthe powerconsumption isdifferent,nothing to dowith the displayfunction
Power	DVI DMPM	DVI DMPM	-
Management	DisplayPort 1.1a	DisplayPort 1.2a
Miscellaneous Features/Specifications
USBPorts/standard	1 upstream (endpoint),2 downstream/ Rev. 2.0	1 upstream (endpoint),2 downstream/ Rev. 2.0	Same
Dimensions w/ostand(W x H x D)	Without stand:376mmx505mmx98 mmWith stand:376mmx599mmx245.5mm	Without stand:356mm x476mm x85mmWith stand:356mm x525mm x238mm	Differenthousing designdue to thedifferent panelsize.
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M33C	JUSHA-M350G/JUSHA-M350/M350G/M350
510(k) Number	K141684	/
Indication foruse	JUSHA-M33C LCD Monitoris intended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device does not supportthe display of mammographyimages for diagnosis.	JUSHA-M350G/JUSHA-M350/M350G/M350 LCDMonitor is intended to beused in displaying andviewing digital images fordiagnosis of X-ray or MRI,etc. by trained medicalpractitioners. The devicedoes not support the displayof mammography images fordiagnosis.	Same
Applicablestandard	1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests.	1 IEC 60601-1:2012,Medical equipment medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance.2 IEC 60601-1-2 Edition4:2014, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticdisturbances - Requirementsand tests.	-

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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 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.

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).