C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor

K230723 · Nanjing Jusha Display Technology Co., Ltd. · PGY · May 18, 2023 · Radiology

Device Facts

• Record ID: K230723
• Device Name: C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Story

C510G is a 21.3-inch color-TFT LCD medical monitor; high resolution (2560x2048); high luminance (1150 cd/m2); 16-bit grayscale (65536 levels). Input via DVI or DisplayPort; processes signals using built-in DICOM standard LUT. Features ambient brightness adaptation, real-time DICOM automatic calibration, full-screen brightness equalization, and presence induction system for automatic adjustment. Used by radiologists/medical practitioners in clinical settings for viewing and diagnosing medical images, specifically breast tomosynthesis. Output is a high-fidelity visual display of medical images; assists clinicians in diagnostic decision-making; benefits patients through accurate, high-resolution visualization of mammographic data.

Clinical Evidence

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

Technological Characteristics

21.3" Color-TFT LCD panel; LED backlight; 2560x2048 resolution; 16-bit LUT; DVI/DisplayPort connectivity. Features: ambient light sensor, auto-calibration sensor, presence induction. Standards: IEC 60601-1, IEC 60601-1-2. Power: DC 24V.

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 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

• JUSHA-M550G (K190848)

Submission Summary (Full Text)

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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 Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street NANJING, JIANGSU 210036 CHINA

May 18, 2023

Re: K230723

Trade/Device Name: C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: March 16, 2023 Received: March 16, 2023

Dear Donny Lee:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K230723

Device Name C510G/JUSHA-C510G/C510/JUSHA-C510

Indications for Use (Describe)

C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# (K230723)

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

| Date: | March 16, 2023 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Donny Lee<br>Certification Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade Name: | C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | Medical image management and processing system 21CFR 892.2050 PGY |
| Product Code: | JUSHA-M550G; K190848 |
| Predicate Device(s): | JUSHA-M550G; K190848 |
| Device Description: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.<br>The product is consisted of the following components:<br>- 21.3" Color-TFT LCD Panel<br>- DMX0704AR1/Main Board/REV: 1.2<br>- C510G LCD Monitor software |

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| | - Power Adapter | | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | - 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>Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic disturbances -<br>Requirements and tests. | | | |
| Intended Use: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is intended<br>to be used in displaying and viewing digital images, including<br>standard and multi-frame digital mammography, for view, analysis,<br>and diagnosis by trained medical practitioners. It is specially designed<br>for breast tomosynthesis applications. | | | |
| Technology: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the<br>display system with the high resolution (2560*2048), high luminance<br>(1150 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM<br>standard LUT. In particular, C510G has ambient brightness adapting,<br>real-time DICOM automatic calibration, full-screen brightness<br>equalization and presence induction system, with these this display<br>can automatic adjustment according to different requirements in order<br>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, EN 60601-1:2013, ANSI/AAMI ES60601-<br>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, Medical<br>electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard: | | | |
| | C510G is substantially equivalent to JUSHA-M550G. C510G<br>employs the maximum resolution values same as that of JUSHA-<br>M550G.<br><br>The following quality assurance measures were applied to the<br>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 C510G<br>LCD Monitor to be as safe, as effective, and performance is<br>substantially equivalent to the predicate device JUSHA-M550G. | | | |

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# Product Comparison

This comparison identifies the similarities and differences of the proposed C510G LCD Monitor device to the legally marketed predicate JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-M550G LCD<br>Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| | | Display Performance/Specifications | |
| Screen<br>technology | 21.3inches, Mono-TFT LCD<br>Panel | 21.3inches, Color-TFT LCD<br>Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 178°,<br>Vertical 178° | Horizontal 178°,<br>Vertical 178° | Same |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x337.9 (V) mm | The two<br>monitors have<br>different front<br>frame style while<br>the M550G<br>employ a Slim<br>Bezel design so<br>that the display<br>area is different. |
| Contrast Ratio | 1700:1 | 2000:1 | C510G has<br>better contrast<br>ratio for the<br>panel, while the<br>difference does<br>not make<br>difference to the<br>diagnosis. |
| DICOM<br>calibrated<br>luminance | 1000cd/m2 | 500cd/m2 | The two models<br>have different<br>panels with<br>different<br>brightness but<br>they have the<br>same resolution<br>for 5MP for<br>Mammo image<br>diagnosis. |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-M550G LCD<br>Monitor | C510G LCD Monitor | Same |
| 510(k) Number | K190848 | K230723 | Same |
| DICOM LUT | 16-bit: 65536 | 16-bit: 65536 | Same |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Video Signal Input | | | |
| 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 | DisplayPort 1.2a | Same |
| Output | DisplayPort x 1 | DisplayPort x 1 | Same |
| Terminational<br>Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | DC 24V | DC 24V | Same |
| Power<br>Consumption/Sa<br>ve Mode | 55W/less than 0.5W | 55W/less than 0.5W | Same |
| 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 Differences |
| Product | JUSHA-M550G LCD Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Dimensions w/o stand<br>(W x H x D) | Without stand:<br>363mm x475mm x66mm<br>With stand:<br>363mm x522mm x238mm | Without stand:<br>399mm x491mm x74mm<br>With stand:<br>399mm x530mm x238mm | Different Dimensions design due to the different structure size. |
| Indication for use | JUSHA-M550G/JUSHA-<br>M550/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 view,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially designed for<br>breast tomosynthesis<br>applications. | C510G/JUSHA-<br>C510G/C510/JUSHA-C510<br>LCD Monitor is intended to<br>be used in displaying and<br>viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for view,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially designed for<br>breast tomosynthesis<br>applications. | Same |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | JUSHA-M550G LCD<br>Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Applicable<br>standard | 1 IEC 60601-1:2012, EN<br>60601-1:2013, ANSI/AAMI<br>ES60601-<br>1:2005+A1:2012+C1:2009+<br>A2:2010, CAN/CSA C22.2<br>NO.60601-1:14, Medical<br>equipment medical electrical<br>equipment - Part 1: General<br>requirements for basic safety<br>and essential<br>performance.<br>2 IEC 60601-1-2 Edition<br>4:2014, EN 60601-1-2:2015,<br>Medical electrical equipment<br>- Part 1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral standard:<br>Electromagnetic disturbances<br>- Requirements and tests | 1 IEC 60601-1:2012, EN<br>60601-1:2013, ANSI/AAMI<br>ES60601-<br>1:2005+A1:2012+C1:2009+<br>A2:2010, CAN/CSA C22.2<br>NO.60601-1:14, Medical<br>equipment medical electrical<br>equipment - Part 1: General<br>requirements for basic safety<br>and essential<br>performance.<br>2 IEC 60601-1-2 Edition<br>4:2014, EN 60601-1-2:2015,<br>Medical electrical equipment<br>- Part 1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral standard:<br>Electromagnetic disturbances<br>- Requirements and tests | Same |

## PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

## Bench testing:

Bench testing was conducted to demonstrate the C510G 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 ●

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- Performance data on luminance stability .
### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the C510G 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, C510G, does not require animal or clinical studies to support substantial equivalence.

## CONCLUSIONS

C510G 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 C510G Medical Display does not raise any new issues of safety or effectiveness.