JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor

K183497 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Jan 15, 2019 · Radiology

Device Facts

• Record ID: K183497
• Device Name: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Jan 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M260G/JUSHA-M260/M260G/M260 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

The JUSHA-M260G/M260 LCD Monitor is a 21.3-inch monochrome diagnostic display system. It accepts digital image inputs via DVI-D or DisplayPort from a medical imaging source. The device transforms these inputs using a built-in DICOM standard Look-Up Table (LUT) and 14-bit grayscale processing to ensure accurate image representation. The M260G model includes a real-time DICOM automatic calibration system with an integrated sensor to maintain luminance stability. Used in clinical settings by trained medical practitioners, the monitor provides high-resolution (1600x1200) visualization of X-ray and MRI images. The output allows clinicians to perform diagnostic evaluations of medical images. The device benefits patients by providing a calibrated, high-quality display environment for accurate radiological diagnosis.

Clinical Evidence

No clinical data or animal studies were required to support substantial equivalence. Evidence consists of bench testing, including measurement of angular dependency of luminance, luminance/chromaticity non-uniformity (per TG18 guidelines), small-spot contrast ratio, temporal response, and luminance stability. Electrical safety and EMC testing confirmed compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

21.3" Mono-TFT LCD panel; LED backlight; 1600x1200 resolution; 14-bit grayscale (16384 levels); built-in DICOM LUT; integrated calibration sensor. Connectivity: DVI-D, DisplayPort, USB 2.0. Power: DC 12V. Standards: IEC 60601-1, IEC 60601-1-2, FCC Part 15.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or MRI. Contraindicated for the display of mammography images.

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-M23C (K151238)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K183497

Device Name

JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor

Indications for Use (Describe)

JUSHA-M260G/JUSHA-M260/M260 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.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 5px;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-left: 20px; padding-right: 5px;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(k) Summary

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<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-M260G/JUSHA-M260/M260G/M260 LCD Monitor | |
| Common/Usual Name: | 2MP monochrome LCD Monitor | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: | PGY | |
| Predicate Device(s): | JUSHA-M23C; K151238 | |
| Device Description: | JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor is the<br>display system with the high resolution (1600*1200), high luminance<br>(800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM<br>standard LUT. In particular, JUSHA-M260G has real-time DICOM<br>automatic calibration system, with these this display can automatic<br>adjustment according to different requirements in order to achieve the<br>best results.<br>The product is consisted of the following components:<br>- 21.3" Mono-TFT LCD Panel<br>- DMX0302CR0/main board/V1.2<br>- JUSHA-M260G LCD Monitor software<br>- Power Adapter<br>- Data Cable. | |
| | accordance with both mandatory and voluntary standards: | |
| | 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+C1:2009+A2:2010,<br>CAN/CSA C22.2 NO.60601-1:14, Medical equipment<br>medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance.<br>2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,<br>CFR 47 FCC Part15 subpart B: 2017, 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-M260G LCD Monitor is intended to be used in displaying<br>and viewing digital images for diagnosis of X-ray or MRI, etc. by<br>trained medical practitioners. The device does not support the display<br>of mammography images for diagnosis. | |
| Technology: | JUSHA-M260G LCD Monitor is the display system with the high<br>resolution (1600*1200), high luminance (800 cd/m2), and 14-bit<br>grayscale (16384 level), built-in DICOM standard LUT. In particular,<br>JUSHA-M260G has real-time DICOM automatic calibration system,<br>with these this display can automatic adjustment according to<br>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: | |
| | 1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2<br>NO.60601-1:14, Medical equipment medical electrical equipment<br>- Part 1: General requirements for basic safety and essential<br>performance.<br>2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47<br>FCC Part15 subpart B: 2017, Medical electrical equipment - Part<br>1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic disturbances -<br>Requirements and tests. | |
| | JUSHA-M260G is substantially equivalent to JUSHA-M23C.<br>JUSHA-M260G employs the maximum resolution values same as that<br>of JUSHA-M23C. Comparison table of the principal characteristics of<br>2 devices is shown in the Attachment 1. | |
| | Attachment 1<br>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-M260G LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | |

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This comparison identifies the similarities and differences of the proposed JUSHA-M260G LCD Monitor device to the legally marketed predicate JUSHA-M23C LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 21.3" Mono-TFT LCD Panel | 21.3" Mono-TFT LCD Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 176°,Vertical<br>176° | Horizontal 178°, Vertical<br>178° | - |
| 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 |
| Scanning<br>frequency (H; V) | 52~76 kHz;59~61Hz | 37.9~75kHz;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 | 500cd/m² | 400cd/m² | 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 |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| DICOM LUT | 12-bit:4096 | 14-bit:16384 | The<br>JUSHA-M260G<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 calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| | | Video Signal Input | |
| Input signals | DVI-D x 1, | DVI-D x 1, | Same |
| | DisplayPort x 1 | DisplayPort x 1 | |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| | | Power Related Specification | |
| Power<br>Requirement | AC 100~240V 50~60Hz | DC 12V | - |
| Power<br>Consumption/Save Mode | 45W/less than 3W | 50W/less than 0.5W | The differences<br>caused by<br>components used<br>in the LCD<br>Monitor. This<br>only shows the<br>power<br>consumption is<br>different,<br>nothing to do<br>with the display<br>function |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| Power<br>Management | DVI DMPM<br>DisplayPort 1.1a | DVI DMPM<br>DisplayPort 1.1a | Same |
| 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>382mm x490mm x75mm<br>With stand:<br>382mm x533mm x238mm | Without stand:<br>382mm x490mm x77mm<br>With stand:<br>382mm x635mm x238mm | Different<br>housing design<br>due to the<br>different panel<br>size. |
| Indication for<br>use | JUSHA-M23C 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-M260G 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 |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------|-------------------------------|-------------------------------|------------------------------|
| Product | JUSHA-M23C | JUSHA-M260G | - |
| 510(k) Number | K151238 | / | - |
| Applicable<br>standard | 1 IEC 60601-1Medical | 1 IEC 60601-1:2012, EN | |
| | equipment medical electrical | 60601-1:2013, ANSI/AAMI | |
| | equipment - Part 1: General | ES60601-1:2005+A1:2012+ | |
| | requirements for basic safety | C1:2009+A2:2010, | |
| | and essential performance | CAN/CSA C22.2 | |
| | 2005+CORR.1(2006)+COR | NO.60601-1:14, Medical | |
| | R.2(2007) | equipment medical electrical | |
| | | equipment - Part 1: General | |
| | 2 IEC 60601-1-2 Edition | requirements for basic safety | |
| | 3:2007, Medical electrical | and essential performance. | |
| | equipment - Part 1-2: | | |
| | General requirements for | 2 IEC 60601-1-2 Edition | |
| | basic safety and essential | 4:2014, EN 60601-1-2:2015, | |
| | performance - Collateral | CFR 47 FCC Part15 subpart | |
| | standard: Electromagnetic | B: 2017, Medical electrical | |
| | compatibility - Requirements | equipment - Part 1-2: | |
| | and tests. | General requirements for | |
| | | basic safety and essential | |
| | | performance - Collateral | |
| | | standard: Electromagnetic | |
| | disturbances - Requirements | | |
| | 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-M260G 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-M260G 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-M260G, does not require animal or clinical studies to support substantial equivalence.

## CONCLUSIONS

JUSHA-M260G Medical Display 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-M260G Medical Display does not raise any new issues of safety or effectiveness.

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January 15, 2019

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

Re: K183497

Trade/Device Name: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 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.

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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 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.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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,

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

Enclosure