JUSHA-C270G/JUSHA-C270/C270G/C270 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C270G has ambient brightness adapting, real-time DICOM automatic calibration and presence induction system, 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 - DMX0302CR0/main board/V1.2 - JUSHA-C270G LCD Monitor software - Power Adapter - Data Cable.

AI/ML Overview

The provided document is a 510(k) summary for the JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (JUSHA-C23C, K151861). The document focuses on demonstrating that the new device is as safe and effective as the predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document defines "acceptance criteria" through compliance with recognized standards and a comparison to a predicate device. The reported performance is based on bench testing.

Acceptance Criteria Category	Specific Acceptance Criteria (from recognized standards or comparison)	Reported Device Performance (JUSHA-C270G)
Electrical Safety	Compliance with 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	Complies with IEC 60601-1 standard for safety.
EMC	Compliance with IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017	Complies with IEC 60601-1-2 standard for EMC.
Display Performance	- Maximum resolution values same as JUSHA-C23C (1600x1200) - Luminance calibration built-in - Contrast Ratio (1400:1) - Pixel Pitch (0.27x0.27 mm) - Ability to display general X-ray or MRI images for diagnosis. - No support for mammography images for diagnosis.	- Resolution: 1600 x 1200 / 1200 x 1600 (Same as predicate) - Luminance calibration: Built-in calibration sensor provided (Same as predicate) - Contrast Ratio: 1400:1 (Same as predicate) - Pixel Pitch: 0.27x0.27 mm (Same as predicate) - Intended for displaying and viewing digital images for diagnosis of X-ray or MRI, etc. (Same as predicate) - Does not support the display of mammography images for diagnosis. (Same as predicate)
Bench Test Metrics	Performance measurements according to TGI18 guideline: - Angular dependency of luminance response - Luminance non-uniformity - Chromaticity non-uniformity - Small-spot contrast ratio - Temporal response - Luminance stability	Bench tests were conducted to demonstrate the JUSHA-C270G meets all performance standards defined by these specific measurements. (Specific numeric results are not provided in this summary).

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

Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical device being tested against established (non-clinical) performance criteria and standards, rather than a dataset of medical images.
Data Provenance: Not applicable for a device performance test. The tests were performed on the device itself.

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

Not applicable. This is a medical display monitor, and its performance evaluation relates to technical specifications and compliance with standards, not diagnostic accuracy based on expert interpretation of images. No ground truth in the sense of medical diagnoses was established for this submission.

4. Adjudication method for the test set:

Not applicable. As noted above, this submission is for a medical display monitor and does not involve adjudication of diagnostic interpretations.

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:

No MRMC comparative effectiveness study was done. This device is a display monitor, not an AI-powered diagnostic tool. Clinical studies were explicitly stated as not required to support substantial equivalence.

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

Not applicable. This device is a display monitor, not an algorithm. Performance tests measured the monitor's technical specifications.

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

Not applicable. The "ground truth" for this device's performance is established by compliance with international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, TGI18 guideline) and comparison to the technical specifications of a predicate device.

8. The sample size for the training set:

Not applicable. This device is a display monitor, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As this is not an algorithm requiring a training set, no ground truth for a training set was established.

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. The logos are displayed side-by-side.

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

February 5, 2019

Re: K183498

Trade/Device Name: JUSHA-C270G/ JUSHA-C270/C270G/C270 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 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 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,

Jeff Bages

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183498

Device Name

JUSHA-C270G/JUSHA=C270/C270G/C270 LCD Monitor

Indications for Use (Describe)

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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K183498

510(k) Summary

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

Date:	December 5, 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- 58783273
Device Trade Name:	JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor
Common/Usual Name:	2MP Color LCD Monitor
Classification Name:	Display, Diagnostic Radiology 21CFR 892.2050
Product Code:	PGY
Predicate Device(s):	JUSHA-C23C; K151861
Device Description:	JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is thedisplay system with the high resolution (1600*1200), high luminance(600 cd/m²), and 281.47 trillion colors, built-in DICOM standardLUT. In particular, JUSHA-C270G has ambient brightness adapting,real-time DICOM automatic calibration and presence inductionsystem, with these this display can automatic adjustment according todifferent requirements in order to achieve the best results.The product is consisted of the following components:- 21.3" Color TFT LCD Panel- DMX0302CR0/main board/V1.2- JUSHA-C270G 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:
Intended Use:	JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is intendedto be used in displaying and viewing digital images for diagnosis ofX-ray or MRI, etc. by trained medical practitioners. The device doesnot support the display of mammography images for diagnosis.
Technology:	JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is thedisplay system with the high resolution (1600*1200), high luminance(600 cd/m2), and 281.47 trillion colors, built-in DICOM standardLUT. In particular, JUSHA-C270G has ambient brightness adapting,real-time DICOM automatic calibration and presence inductionsystem, with these this display can automatic adjustment according todifferent 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor issubstantially equivalent to JUSHA-C23C.JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor employsthe maximum resolution values same as that of JUSHA-C23C.Comparison table of the principal characteristics of 2 devices isshown in the Attachment 1.Attachment 1The following quality assurance measures were applied to thedevelopment 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 predicatedevice which is US legally market device. Therefore, the subjectdevice is determined as safe and effectiveness.
Conclusion:	Nanjing Jusha Display Technology Co., Ltd Considers theJUSHA-C270G LCD Monitor to be as safe, as effective, andperformance 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-C270G LCD Monitor device to the legally marketed predicate JUSHA-C33C LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C23C	JUSHA-C270G/JUSHA-C270/C270G/C270 LCDMonitor
510(k) Number	K151861	/
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	1600 x 1200/1200 x 1600	1600 x 1200/1200 x 1600	Same
Display area	432.0 (H) x 324.0(V) mm	432.0 (H) x 324.0(V) mm	Same
Contrast Ratio	1400:1	1400:1	Same
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C23C	JUSHA-C270G/JUSHA-C270/C270G/C270 LCDMonitor
510(k) Number	K151861	/
Scanningfrequency (H; V)	52~~76 kHz;59~~61Hz	37.9~75kHz;60Hz	This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers ,nothing to dowith the displayfunction
RecommendedLuminance	400cd/m²	350cd/m²	This differencebetween the twodevices is causedby factorysetting, nothingto do with thedisplay function
Pixel Pitch	0.27x0.27 mm	0.27x0.27 mm	Same
Backlight	LED	LED	Same.
Display Colors	12-bit	16-bit	TheJUSHA-C270GLCD 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
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C23C	JUSHA-C270G/JUSHA-C270/C270G/C270 LCDMonitor
510(k) Number	K151861	/
Input signals	DVI-D x 1,DisplayPort x 1	DVI-D x 1,DisplayPort x 1	same
Displaycontroller	Off the shelf	Off the shelf	Same
Power Related Specification
PowerRequirement	AC 100~~240V 50~~60Hz	DC 24V	-
PowerConsumption/Save Mode	65W/less than 2.5W	50W/less than 0.5W	The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction
Power	DVI DMPM	DVI DMPM	Same
Management	DisplayPort 1.1a	DisplayPort 1.1a
Miscellaneous Features/Specifications
USB	1 upstream (endpoint),	1 upstream (endpoint),	Same
Ports/standard	2 downstream/ Rev. 2.0	2 downstream/ Rev. 2.0
Dimensions w/o	Without stand:382mm x490mm x75mm	Without stand:382mm x490mm x77mm	Different
stand	With stand:382mm x533mm x238mm	With stand:382mm x635mm x238mm	housing design
(W x H x D)			due to thedifferent panelsize.
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-C23C	JUSHA-C270G/JUSHA-C270/C270G/C270 LCDMonitor
510(k) Number	K151861	/
Indication foruse	JUSHA-C23C 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-C270G 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, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpartB: 2017, 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-C270G 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-C270G 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-C270G, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

JUSHA-C270G/JUSHA-C270/C270G/C270 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-C270G 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).