JUSHA-CP610 LCD Monitor

K200742 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Jul 24, 2020 · Radiology

Device Facts

• Record ID: K200742
• Device Name: JUSHA-CP610 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Jul 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-CP610/CP610 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

JUSHA-CP610 is a portable 13.5-inch color TFT LCD medical display monitor (850g). It receives digital image data (X-ray, MRI) from a host computer via Type-C or Mini DP interfaces. The device features 3000x2000 resolution, 300 cd/m² luminance, and 14-bit color depth. It incorporates a built-in DICOM standard Look-Up Table (LUT) and automatic adjustment capabilities to optimize image display. Operated by medical practitioners in clinical settings, the monitor provides high-resolution visual output for diagnostic review. It includes grayscale expansion and signal scanning/switching modules to enhance image clarity. The device benefits patients by providing a portable, high-quality diagnostic viewing solution for medical imaging.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including luminance response, luminance/chromaticity non-uniformity (TG18 guidelines), small-spot contrast ratio, temporal response, and luminance stability, alongside electrical safety and EMC compliance.

Technological Characteristics

13.5" Color TFT LCD panel; LED backlight; 3000x2000 resolution; 14-bit color depth; 300 cd/m² luminance; 1800:1 contrast ratio. Connectivity: Type-C, Mini DP, USB 3.1. Standards: IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005, CAN/CSA C22.2 NO.60601-1:14, IEC 60601-1-2 Edition 4:2014. Features built-in DICOM LUT, grayscale expansion, and signal scanning/switching.

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-C61 (K141679)

Submission Summary (Full Text)

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July 24, 2020

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

#### Re: K200742

Trade/Device Name: JUSHA-CP610 LCD Monitor, CP610 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 1, 2020 Received: July 1, 2020

#### Dear Mr. 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 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/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 mediation-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.

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) K200742

Device Name JUSHA-CP610 LCD Monitor, CP610 LCD Monitor

Indications for Use (Describe)

JUSHA-CP610 LCD Monitor, CP610 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)

| <div><span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-family: Arial;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary

# K200742

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

| Date: | September 23, 2019 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd<br>Add: 301, 8F Block A, No.1, Nanjing International Service Outsourcing<br>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-CP610 LCD Monitor, CP610 LCD Monitor |
| Common/Usual Name: | 6MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Regulatory name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II |
| Predicate Device(s): | JUSHA-C61; K141679<br>Classification Name: Display, Diagnostic Radiology 21CFR 892.2050<br>Product Code: PGY<br>Regulatory name: Picture Archiving and Communications System<br>Regulatory Class: Class II |
| Device Description: | JUSHA-CP610/CP610 LCD Monitor is the display system with the high<br>resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion<br>colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD<br>Monitor is portable and light, the 850g weight make it is easy to carry. With<br>these this display can automatic adjustment according to different<br>requirements in order to achieve the best results.<br>The product is consisted of the following components:<br>- 13.5" Color TFT LCD Panel<br>- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1<br>- JUSHA-CP610 LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br><br>The software that supports the functions of the CP610 is the same as the<br>software used with the predicate JUSHA C61. The level of concern was<br>determined to be Moderate for the JUSHA-CP610 LCD Monitor.<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, EN 60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA |
| | C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.<br>2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-CP610/CP610 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. |
| Technology: | JUSHA-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results. |
| Determination of Substantial 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 ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.<br>2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.<br>JUSHA-CP610 /CP610 LCD Monitor is substantially equivalent to JUSHA-C61. JUSHA-CP610 LCD/CP610 LCD Monitor employs the maximum resolution values same as that of JUSHA-C61. At a high level, the subject and predicate devices are based on the following same technological elements:<br>• Maximum resolution: 6megapixels<br>• Screen technology: Color TFT LCD Panel<br>• Viewing angle: Horizontal 170°,Vertical 170°<br>• LED Backlight<br>• Intended Use<br>• Software function: DICOM calibration function and The host computer communication. |
| predicate devices: | |
| • | Screen Size: The subject device uses a smaller screen size to reduce weight and improve the portability. |
| • | Display Colors: The subject device uses a color bit expansion technology to improve image display quality, the image clarity is better than the image displayed on the predicate device. |
| • | Software function: The new functions Grayscale expansion and Signal scanning and switching module were used in the subject device. |
| 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-CP610 LCD Monitor to be as safe, as effective, 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-CP610 LCD Monitor device to the legally marketed predicate JUSHA-C61 LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Display Performance/Specifications | | | |
| Screen technology | 30" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | The<br>JUSHA-CP610<br>LCD Monitor<br>uses a smaller<br>LCD Panel to<br>reduce weight<br>and improve<br>the portability of<br>the device. |
| Viewing angle<br>(H, V) | Horizontal 170°,Vertical<br>170° | Horizontal 170°,Vertical<br>170° | Same |
| Resolution | $3280×2048$ | $3000×2000$ | This difference<br>between the two<br>devices is caused<br>by the LCD<br>Panel, and the<br>JUSHA CP610<br>LCD Monitor<br>could also meet<br>the requirement<br>of 6megapixels. |
| Display area | 403.0(V) ×645.5(H) mm | 285.3(V)×190.2(H)mm | - |
| Contrast Ratio | 1000:1 | 1800:1 | - |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Scanning<br>frequency (H; V) | 52~76kHz; 59~61Hz | 94.94~123.84kHz; 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 | 300cd/m² | This difference<br>between the two<br>devices is caused<br>by factory<br>setting, nothing<br>to do with the<br>display function |
| Pixel Pitch | 0.197×0.197 mm | 0.0951×0.0951mm | The<br>JUSHA-CP610<br>LCD uses a<br>smaller Pixel<br>Pitch to improve<br>the pixel density. |
| Backlight | LED | LED | Same. |
| Display Colors | 12-bit , 68.7 billion colors | 14-bit, 4398 billion colors | The<br>JUSHA-CP610<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. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Luminance<br>calibration | Built in calibration sensor<br>provided | General calibration sensor | The JUSHA<br>CP610 LCD<br>Monitor use the<br>general sensor to<br>instead the<br>build-in sensor<br>to reduce weight<br>and improve the<br>portability of the<br>device |
| Video Signal Input | | | |
| Input signals | DVI-D Dual Link x2<br>Display Port x2 | Type-C×1,<br>Mini DP×1 | - |
| Output signals | - | - | - |
| 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/Save Mode | 100W/less than 1.5W | 15W / N/A | 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 1.1a | N/A | - |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| USB<br>Ports/standard | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | upstream (endpoint)/Rev.<br>3.1 | - |
| Dimensions (W x H x D) | Without stand:<br>704mm x 478mm x 81mm<br><br>With stand:<br>704mm x 611mm x292mm | 323mm×225×11.5mm | Different<br>housing design<br>due to the<br>different panel<br>size. |
| Indication for<br>use | JUSHA-C61 LCD Monitor<br>is intended to be used in<br>displaying and viewing<br>digital images for review and<br>analysis by trained medical<br>practitioners. It does not<br>support the display of<br>mammography images for<br>diagnosis. | JUSHA-CP610 LCD<br>Monitor is intended to be<br>used…