JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor

K183496 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Apr 8, 2019 · Radiology

Device Facts

• Record ID: K183496
• Device Name: JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Apr 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

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 Story

3MP color LCD monitor for high-resolution medical image evaluation; inputs digital signals via DVI-D or DisplayPort; features automatic signal identification (CGA function) to apply DICOM LUT for grayscale areas and GAMMA2.2 LUT for color areas; includes ambient brightness adaptation, 3D LUT color calibration, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction, and focusview function; used in clinical settings by medical practitioners; output enables diagnostic review of X-ray and MRI images; benefits include improved image quality and automated display adjustments for diagnostic accuracy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including luminance response, non-uniformity (TG18), contrast ratio, temporal response, and electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

21.3" Color TFT LCD panel; LED backlight; 3MP resolution (2048x1536); 800 cd/m² luminance; 16-bit color (281.47 trillion colors); 1400:1 contrast ratio; built-in calibration sensor; DVI-D and DisplayPort inputs; 24V DC power; IEC 60601-1 and IEC 60601-1-2 compliant.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or MRI. Not indicated for mammography image diagnosis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• JUSHA-C33C (K141684)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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., Ltd<br>Add: 301, 8F Block A, No.1, Nanjing International Service<br>Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China |
| Contact Person: | Zilong Liang<br>Certification Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor ,<br>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 ,<br>C350G LCD Monitor , C350 LCD Monitor is the display system with<br>the high resolution monitor (3 megapixels) with electronic capabilities<br>for evaluation of high resolution medical images, high luminance (800<br>cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT.<br>JUSHA-C350G LCD Monitor contains CGA function, it is specially<br>made by JUSHA, it can automatic identify gray and color signals,<br>then gray area calls DICOM LUT and color area calls GAMMA2.2<br>LUT. In addition, JUSHA-C350G has ambient brightness adapting,<br>3D LUT color calibration, real-time DICOM automatic calibration,<br>Full-screen brightness equalization, presence induction and focusview<br>function, with these this display can automatic adjustment accordingThe product is consisted of the following components:<br>- 21.3" Color TFT LCD Panel<br>- DMX0704AR0/main board/REV1.1<br>- JUSHA-C350G LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br>The LCD Monitor is designed, tested, and will be manufactured in<br>accordance with both mandatory and voluntary standards:<br>1. IEC 60601-1:2012, Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic safety |
| | and essential performance. |
| | 2. IEC 60601-1-2 Edition 4:2014, Medical electrical<br>equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,<br>C350G LCD Monitor, C350 LCD Monitor is intended to be used in<br>displaying and viewing digital images for diagnosis of X-ray or MRI,<br>etc. by trained medical practitioners. The device does not support the<br>display of mammography images for diagnosis. |
| Technology: | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,<br>C350G LCD Monitor, C350 LCD Monitor is the display system with<br>the high resolution monitor (3 megapixels) with electronic capabilities<br>for evaluation of high resolution medical images, high luminance (800<br>cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT.<br>JUSHA-C350G LCD Monitor contains CGA function, it is specially<br>made by JUSHA, it can automatic identify gray and color signals,<br>then gray area calls DICOM LUT and color area calls GAMMA2.2<br>LUT. In addition, JUSHA-C350G has ambient brightness adapting,<br>3D LUT color calibration, real-time DICOM automatic calibration,<br>Full-screen brightness equalization, presence induction and focusview<br>function, with these this display can automatic adjustment according<br>to different requirements in order to achieve the best results. |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The LCD Monitor complies with voluntary standards as following:<br>1 IEC 60601-1:2012, Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic safety and<br>essential performance.<br>2 IEC 60601-1-2 Edition 4:2014, Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic disturbances -<br>Requirements and tests.<br>JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,<br>C350G LCD Monitor, C350 LCD Monitor is substantially equivalent<br>to JUSHA-C33C. JUSHA-C350G employs the maximum resolution<br>values same as that of JUSHA-C33C. Comparison table of the<br>principal characteristics of 2 devices is shown in the Attachment 1.<br>Attachment 1<br>The following quality assurance measures were applied to the<br>development of the system:<br>• Risk Analysis<br>• Requirements Reviews<br>• 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:<br>The subject of this premarket submission, LCD Monitor, did not<br>require clinical studies to support substantial equivalence.<br>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<br>JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,<br>C350G LCD Monitor, C350 LCD Monitor to be as safe, as effective,<br>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 | Discussion of<br>Differences |
|------------------------------------|------------------|----------------------------|------------------------------|
| Product | JUSHA-C33C | JUSHA-C350G LCD<br>Monitor | |
| 510(k) Number | K141684 | / | |
| Display Performance/Specifications | | | |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C33C | JUSHA-C350G LCD<br>Monitor | |
| 510(k) Number | K141684 | / | |
| Screen<br>technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 176°,Vertical<br>176° | Horizontal 178°,Vertical<br>178° | - |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 | Same |
| Display area | 324.864(H) x 433.152<br>(V)<br>mm | 323.942(H) x 431.923<br>(V)<br>mm | - |
| Contrast Ratio | 1400:1 | 1400:1 | same |
| Scanning<br>frequency (H; V) | 96.7kHz;60Hz | 37.9~95.4kHz;60Hz | This difference<br>between the two<br>device is caused<br>by the different<br>no display area<br>defined by<br>different<br>manufacturers ,<br>nothing to do<br>with the display<br>function |
| Recommended<br>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<br>Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD<br>Monitor | - |
| 510(k) Number | K141684 | / | - |
| Display Colors | 12-bit, 68.7 billion colors | 16-bit, 281.47 Trillion<br>colors | The<br>JUSHA-C350G<br>LCD Monitor<br>uses a color bit<br>expansion<br>technology to<br>improve image<br>display quality,<br>the image clarity<br>is better than the<br>image displayed<br>on the predicate<br>device. |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Video Signal Input | | | |
| Input signals | DVI-D (dual link) x 1,<br>DisplayPort x 1 | DVI-D (dual link) x 1,<br>DisplayPort x 1 | - |
| Output Signal | - | DisplayPort x1 | - |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | AC 100~240V 50~60Hz | DC 24V | - |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD<br>Monitor | |
| 510(k) Number | K141684 | / | |
| Power<br>Consumption/Sa<br>ve Mode | 65W/less than 3W | 80W/less than 0.5W | The differences<br>caused by<br>different adapter<br>and components<br>used in the LCD<br>Monitor, the<br>JUSHA-C350G<br>has more power<br>consumption and<br>lower save mode<br>power<br>consumption.<br>This only shows<br>the power<br>consumption is<br>different,<br>nothing to do<br>with the display<br>function |
| Power | DVI DMPM | DVI DMPM | - |
| Management | DisplayPort 1.1a | DisplayPort 1.2a | |
| Miscellaneous Features/Specifications | | | |
| USB<br>Ports/standard | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | Same |
| Dimensions w/o<br>stand<br>(W x H x D) | Without stand:<br>376mmx505mmx98 mm | Without stand:<br>356mm x476mm x85mm<br>With stand: | Different<br>housing design<br>due to the<br>different panel |
| | With stand:<br>376mmx599mmx245.5mm | 356mm x525mm x238mm | size. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD Monitor | |
| 510(k) Number | K141684 | / | |
| Indication for use | JUSHA-C33C LCD Monitor<br>is intended to be used in<br>displaying and viewing<br>digital images for diagnosis<br>of X-ray or MRI, etc. by<br>trained medical practitioners.<br>The device does not support<br>the display of mammography<br>images for diagnosis. | JUSHA-C350G LCD<br>Monitor is intended to be<br>used in displaying and<br>viewing digital images for<br>diagnosis of X-ray or MRI,<br>etc. by trained medical<br>practitioners. The device<br>does not support the display<br>of mammography images for<br>diagnosis. | Same |
| Applicable<br>standard | 1 IEC 60601-1Medical<br>equipment medical electrical<br>equipment - Part 1: General<br>requirements for basic safety<br>and essential performance<br>2005+CORR.1(2006)+COR<br>R.2(2007)<br>2 IEC 60601-1-2 Edition<br>3:2007, Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements<br>and tests. | 1 IEC 60601-1:2012,<br>Medical equipment medical<br>electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential<br>performance.<br>2 IEC 60601-1-2 Edition<br>4:2014, Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>disturbances - Requirements<br>and 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.