JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor

K190848 · Nanjing Jusha Display Technology Co., Ltd. · PGY · May 14, 2019 · Radiology

Device Facts

• Record ID: K190848
• Device Name: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: May 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Story

JUSHA-M550G/M550 is a 21.3-inch high-resolution (2560x2048) monochrome TFT LCD medical monitor. It receives digital image inputs via DVI or DisplayPort. The device features a 16-bit grayscale LUT, 1000 cd/m2 luminance, and built-in calibration sensors. Operational features include ambient brightness adaptation, real-time DICOM automatic calibration, full-screen brightness equalization, and a presence induction system for power management. Used in clinical settings by radiologists and trained medical practitioners for diagnostic review of mammography and breast tomosynthesis images. The monitor provides high-clarity visual output to assist clinicians in diagnostic decision-making, potentially improving diagnostic accuracy for breast imaging.

Clinical Evidence

No clinical data or animal studies were required or provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and display performance metrics (luminance response, uniformity, chromaticity, contrast ratio, and temporal response) following TG18 guidelines.

Technological Characteristics

21.3" Mono-TFT LCD panel; 2560x2048 resolution; 1000 cd/m2 luminance; 16-bit grayscale LUT; LED backlight. Connectivity: DVI 1.0, DisplayPort 1.2a. Features: ambient light sensor, built-in calibration sensor, presence induction. Standards: IEC 60601-1, IEC 60601-1-2, FCC Part 15. Power: 100-240V AC.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including standard and multi-frame digital mammography and breast tomosynthesis, for review, analysis, and 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

• BARCO MDMG-5221 (K161229)

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

### Re: K190848

Trade/Device Name: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: Class II Product Code: PGY Dated: April 10, 2019 Received: April 10, 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.

May 14, 2019

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190848

Device Name

JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor

Indications for Use (Describe)

JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Type of Use (Select one or both, as applicable)

| <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

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

| Date: | February 26, 2019 |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| | 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-M550G/JUSHA-M550/M550G/M550 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050<br>PGY |
| Product Code: | |
| Predicate Device(s): | BARCO MDMG-5221; K161229 |
| Device Description: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is the<br>display system with the high resolution (2560*2048), high luminance<br>(1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM<br>standard LUT. In particular, JUSHA-M550G has ambient brightness<br>adapt inside. In particular, JUSHA-M550G has ambient brightness<br>adapting, real-time DICOM automatic calibration, full-screen<br>brightness equalization and presence induction system, with these this<br>display can automatic adjustment according to different requirements<br>in order to achieve the best results.<br>The product is consisted of the following components:<br>- 21.3" Mono-TFT LCD Panel<br>- DMX0704AR0/main board/REV1.1<br>- JUSHA-M550G LCD Monitor software<br>- Power Adapter<br>- Data Cable |
| The LCD Monitor is designed, tested, and will be manufactured in<br>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. |
| | 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-M550G/JUSHA-M550/M550G/M550 LCD Monitor is<br>intended to be used in displaying and viewing digital images,<br>including standard and multi-frame digital mammography, for review,<br>analysis, and diagnosis by trained medical practitioners. It is specially<br>de displaying and viewing digital images, including standard and<br>multi-frame digital mammography, for review, analysis, and diagnosis<br>by trained medical practitioners. It is specially designed for breast<br>tomosynthesis applications. |
| Technology: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is the<br>display system with the high resolution (2560*2048), high luminance<br>(1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM<br>standard LUT. In particular, JUSHA-M550G has ambient brightness<br>adapt inside. In particular, JUSHA-M550G has ambient brightness<br>adapting, real-time DICOM automatic calibration, full-screen<br>brightness equalization and presence induction system, with these this<br>display can automatic adjustment according to different requirements<br>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. |
| | 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 |
| | Requirements and tests |
| | JUSHA-M550G is substantially equivalent to BARCO MDMG-5221.<br>JUSHA-M550G employs the maximum resolution values same as that<br>of BARCO MDMG-5221. Comparison table of the principal<br>characteristics of 2 devices is shown in the Attachment 1. |
| | Attachment 1 |
| | The following quality assurance measures were applied to the<br>development of the system: |
| | • Risk Analysis<br>• Requirements Reviews<br>• Design Reviews<br>• Raw materials verification<br>• Testing on unit level (Module verification)<br>• Integration testing (System verification)<br>• Final acceptance testing (Validation)<br>• Performance testing (Verification)<br>• Safety testing (Verification) |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, LCD Monitor, did not<br>require clinical studies to support substantial equivalence.<br><br>The proposed device is Substantially Equivalent (SE) to the predicate<br>device which is US legally market device. Therefore, the subject<br>device is determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the<br>JUSHA-M550G LCD Monitor to be as safe, as effective, and<br>performance is substantially equivalent to the predicate device(s) |

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This comparison identifies the similarities and differences of the proposed JUSHA-M550G LCD Monitor device to the legally marketed predicate BARCO MDMG-5221 LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD<br>Monitor | |
| 510(k) Number | K161229 | / | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 21.3inches, Mono-TFT LCD<br>Panel | 21.3inches, Mono-TFT LCD<br>Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 176°,Vertical<br>176° | Horizontal 170°, Vertical<br>170° | - |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x377.92(V) mm | - |
| Contrast Ratio | 950:1 | 1700:1 | - |
| DICOM<br>calibrated<br>luminance | 1000cd/m2 | 1000cd/m2 | Same |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same. |
| DICOM LUT | 10-bit:1024 | 16-bit:65536 | The<br>JUSHA-M550G<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 | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD<br>Monitor | |
| 510(k) Number | K161229 | / | |
| Input signals | DVI standard 1.0,<br>DisplayPort 1.2a | DVI standard 1.0,<br>DisplayPort 1.2a | Same |
| Input<br>terminational | DVI-D x 1,<br>DisplayPort x 1 | DVI-D x 1,<br>DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| Terminational | | | |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| | | Power Related Specification | |
| Power<br>Requirement | AC 100~240V 50~60Hz | AC 100~240V 50~60Hz | Same |
| Power<br>Consumption/Sa<br>ve Mode | 57W/less than 0.7W | 55W/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 |
| Power<br>Management | DVI DMPM<br>DisplayPort 1.2a | DVI DMPM<br>DisplayPort 1.2a | 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 |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Dimensions w/o<br>stand<br>(W x H x D) | Without stand:<br>392mm x484mm x122mm<br>With stand:<br>780mm x550mm x261mm | Without stand:<br>363mm x475mm x66mm<br>With stand:<br>363mm x635mm x238mm | Different<br>housing design<br>due to the<br>different panel<br>size. |
| Indication for<br>use | BARCO MDMG-5221<br>device intended to be used in<br>displaying and viewing<br>digital images, including<br>standard and multi-frame<br>digital mammography, for<br>review, analysis, and<br>diagnosis by trained medical<br>practitioners. It is specially<br>de displaying and viewing<br>digital images, including<br>standard and multi-frame<br>digital mammography, for<br>review, analysis, and<br>diagnosis by trained medical<br>practitioners. It is specially<br>designed for breast<br>tomosynthesis applications. | JUSHA-M550G/JUSHA-M5<br>50/M550G/M550 LCD<br>Monitor is intended to be<br>used in displaying and<br>viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially de displaying<br>and viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially designed for<br>breast tomosynthesis<br>applications. | Same |
| Attributes | Predicate Device…