JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 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-C350G LCD Monitor , JUSHA-C350 LCD Monitor , C350G LCD Monitor , C350 LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (800 cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. JUSHA-C350G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C350G has ambient brightness adapting, 3D LUT color calibration, 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" Color TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-C350G 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, 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.

AI/ML Overview

The document provided is a 510(k) summary for a medical LCD monitor, the JUSHA-C350G, and does not describe an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

Specifically, the document focuses on demonstrating substantial equivalence of the JUSHA-C350G LCD Monitor to a predicate device (JUSHA-C33C) based on performance specifications and compliance with electrical safety and EMC standards. It explicitly states that "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, JUSHA-C350G, does not require animal or clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information for an AI/ML device, as this document pertains to a medical display monitor and does not involve AI/ML technology or associated performance criteria for such systems.

If you have a document describing an AI/ML medical device, please provide it, and I will do my best to extract the relevant information.

Summary

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Image /page/0/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 8, 2019

Re: K183496

Trade/Device Name: JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 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

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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 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.

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

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510(k) Summary

K183496

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

Date:	December 1, 2018
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China
Contact Person:	Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271
Device Trade Name:	JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor ,C350G LCD Monitor , C350 LCD Monitor
Common/Usual Name:	3MP Color LCD Monitor
Classification Name:	Display, Diagnostic Radiology 21CFR 892.2050
Product Code:	PGY
Predicate Device(s):	JUSHA-C33C; K141684
Device Description:	JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor ,C350G LCD Monitor , C350 LCD Monitor is the display system withthe high resolution monitor (3 megapixels) with electronic capabilitiesfor evaluation of high resolution medical images, high luminance (800cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT.JUSHA-C350G LCD Monitor contains CGA function, it is speciallymade by JUSHA, it can automatic identify gray and color signals,then gray area calls DICOM LUT and color area calls GAMMA2.2LUT. In addition, JUSHA-C350G has ambient brightness adapting,3D LUT color calibration, real-time DICOM automatic calibration,Full-screen brightness equalization, presence induction and focusviewfunction, with these this display can automatic adjustment accordingThe product is consisted of the following components:- 21.3" Color TFT LCD Panel- DMX0704AR0/main board/REV1.1- JUSHA-C350G 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, Medical equipment medical electricalequipment - Part 1: General requirements for basic safety
	and essential performance.
	2. IEC 60601-1-2 Edition 4:2014, Medical electricalequipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests.
Intended Use:	JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,C350G LCD Monitor, C350 LCD Monitor is intended to be used indisplaying and viewing digital images for diagnosis of X-ray or MRI,etc. by trained medical practitioners. The device does not support thedisplay of mammography images for diagnosis.
Technology:	JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,C350G LCD Monitor, C350 LCD Monitor is the display system withthe high resolution monitor (3 megapixels) with electronic capabilitiesfor evaluation of high resolution medical images, high luminance (800cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT.JUSHA-C350G LCD Monitor contains CGA function, it is speciallymade by JUSHA, it can automatic identify gray and color signals,then gray area calls DICOM LUT and color area calls GAMMA2.2LUT. In addition, JUSHA-C350G has ambient brightness adapting,3D LUT color calibration, real-time DICOM automatic calibration,Full-screen brightness equalization, presence induction and focusviewfunction, with these this display can automatic adjustment accordingto 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, Medical equipment medical electricalequipment - Part 1: General requirements for basic safety andessential performance.2 IEC 60601-1-2 Edition 4:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic disturbances -Requirements and tests.JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,C350G LCD Monitor, C350 LCD Monitor is substantially equivalentto JUSHA-C33C. JUSHA-C350G employs the maximum resolutionvalues same as that of JUSHA-C33C. Comparison table of theprincipal characteristics of 2 devices is shown in the Attachment 1.Attachment 1The following quality assurance measures were applied to thedevelopment of the system:• Risk Analysis• Requirements Reviews• Design Reviews
	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 notrequire 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 theJUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,C350G LCD Monitor, C350 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-C350G LCD Monitor device to the legally marketed predicate JUSHA-C33C LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device
Product	JUSHA-C33C	JUSHA-C350G LCDMonitor
510(k) Number	K141684	/
Display Performance/Specifications

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Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C33C	JUSHA-C350G LCDMonitor
510(k) Number	K141684	/
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-C33C	JUSHA-C350G LCDMonitor	-
510(k) Number	K141684	/	-
Display Colors	12-bit, 68.7 billion colors	16-bit, 281.47 Trillioncolors	TheJUSHA-C350GLCD 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 x1	-
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-C33C	JUSHA-C350G LCDMonitor
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-C350Ghas 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 mm	Without stand:356mm x476mm x85mmWith stand:	Differenthousing designdue to thedifferent panel
	With stand:376mmx599mmx245.5mm	356mm x525mm x238mm	size.
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C33C	JUSHA-C350G LCD Monitor
510(k) Number	K141684	/
Indication for use	JUSHA-C33C 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-C350G 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-C350G 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-C350G 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-C350G, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

JUSHA-C350G/JUSHA-C350/C350G/C350 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 should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-C350G Medical Display 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).