CP620G LCD monitor, CP620 LCD monitor

K230643 · Nanjing Jusha Display Technology Co., Ltd. · PGY · May 1, 2023 · Radiology

Device Facts

• Record ID: K230643
• Device Name: CP620G LCD monitor, CP620 LCD monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: May 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CP620G/CP620 LCD Monitor is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Story

CP620G/CP620 is a 13.5-inch color TFT LCD monitor for medical image review. It accepts digital video signals via Type-C or HDMI inputs and displays images at 3000x2000 resolution with 500 cd/m² luminance. Operated by medical practitioners in clinical settings, the device features a built-in DICOM standard LUT for image consistency. New features include a gravity sensor for automatic screen rotation, ambient light monitoring for adaptive brightness/DICOM compensation, and a touch screen interface for PACS interaction. It also supports bidirectional power delivery via USB-C and dual-screen display modes. The device is portable (750g) and designed to assist clinicians in reviewing diagnostic images, potentially improving workflow efficiency and diagnostic comfort through its adaptive display capabilities.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via measurement of luminance response, non-uniformity (luminance/chromaticity), small-spot contrast ratio, temporal response, and luminance stability. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

13.5" Color TFT LCD panel; 3000x2000 resolution; 500 cd/m² luminance; 1800:1 contrast ratio; LED backlight; 14-bit color depth (4.398 billion colors). Connectivity: Type-C, HDMI, USB 3.1. Features: Built-in DICOM LUT, gravity sensor, ambient light sensor, touch screen. Standards: IEC 60601-1:2012, IEC 60601-1-2:2014. Power: 100-240V AC.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review and analysis. Not indicated for the display of mammography images for 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-CP610 (K200742)

Submission Summary (Full Text)

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Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. No. 301, Hanzhongmen Street Nanjing, Jiangsu 210036 CHINA

### May 1, 2023

# Re: K230643

Trade/Device Name: CP620G LCD monitor, CP620 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 9, 2023 Received: March 9, 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 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 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, Ph.D. 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) K230643

Device Name CP620G LCD Monitor / CP620 LCD Monitor

Indications for Use (Describe)

CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

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

| <label> <input checked="checked" type="checkbox"/> Research Use (Part 1, CFR 301 Subpart D) </label> |
|--------------------------------------------------------------------------------------------------------------------|
| <label> <input type="checkbox"/> Commodity Use (Part 1, CFR 319) </label> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# (K230643)

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

| Date: | Mar 3, 2023 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd<br>Add: 8A, Block 1. Nanjing International Service Outsourcing Mansion,<br>No. 301, Hanzhongmen street, Nanjing City, Jiangsu Province, 210036<br>China. |
| Contact Person: | Donny Lee<br>Certification Engineer<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade<br>Name: | CP620G LCD Monitor, CP620 LCD Monitor |
| Common/Usual<br>Name: | 6MP Color LCD Monitor |
| Classification<br>Name: | Medical Image Management and Processing System, 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| Predicate<br>Device(s): | JUSHA-CP610; K200742 |
| Classification<br>Name: | Medical Image Management and Processing System ,21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| Device<br>Description: | CP620G/CP620 LCD Monitor is the display system with the high<br>resolution (3000*2000), high luminance (500 cd/m2), and 4398 billion |
| | Monitor is portable and light, the 750g weight make it is easy to carry.<br>With these this display can automatic adjustment according to different<br>requirements in order to achieve the best results.(There is no difference<br>between CP620G and CP620 except for labeling as they are marketed<br>in different areas. CP620G is global sales, CP620 is domestic sales .It<br>does not affect their safety or effectiveness in any terms. )<br>The product is consisted of the following components:<br>- 13.5" Color-TFT LCD Panel<br>- DMS3400AR0/6 layers/214*150mm/1.0mm/REV:1.0<br>- CP620G LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br>In accordance with the May 11, 2005 Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical Devices, the<br>software level of concern for the CP620G/CP620 LCD Monitor was<br>determined to be Moderate on account of a failure or latent flaw could<br>indirectly result in minor injury to the patient or operator through incorrect<br>or delayed information or through the action of a care provider. the<br>software doesn't include any functions of image manipulation.<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<br>C22.2 NO.60601-1:14, 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, EN 60601-1-2:2015, Medical<br>electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | CP620G/CP620 LCD Monitor is intended to be used in displaying and<br>viewing digital images for review and analysis by trained medical<br>practitioners. It does not support the display of mammography images for<br>diagnosis. |
| Technology: | CP620G/CP620 LCD Monitor is the display system with the high<br>resolution (3000*2000), high luminance (500 cd/m²), and 4.398 billion |
| colors, built-in DICOM standard LUT. In particular, CP620G/CP620 LCD<br>Monitor is portable and light, the 750 g weight make it is easy to carry.<br>With these this display can automatic adjustment according to different<br>requirements in order to achieve the best results. | |
| Determination of<br>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<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, Medical<br>electrical equipment - Part 1-2: General requirements for basic safety<br>and essential performance - Collateral standard: Electromagnetic<br>disturbances - Requirements and tests<br>CP620G LCD Monitor are substantially equivalent to JUSHA-CP610<br>LCD Monitor. They have equivalent characteristics and functions<br>according to comparison table, please refer to 2. Product Comparison<br>The following quality assurance measures were applied to the<br>development of the system:<br>• 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)<br>Summary of Clinical Tests:<br>The subject of this premarket submission, LCD Monitor, did not require<br>clinical studies to support substantial equivalence.<br>The proposed device is Substantially Equivalent (SE) to the predicate<br>device which is US legally market device. Therefore, the subject device is<br>determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the<br>CP620G/CP620 LCD Monitor to be as safe as effective and performance |
| | is substantially equivalent to the predicate device(s). |

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# 2. Product Comparison

This comparison identifies the similarities and differences of the proposed CP620G LCD Monitor device to the legally marketed predicate JUSHA-CP610 LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------------------|----------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | Same |
| Viewing<br>angle<br>(H, V) | Horizontal 170°,Vertical<br>170° | Horizontal 170°,Vertical<br>170° | Same |
| Resolution | 3000×2000 | 3000×2000 | Same |
| Display area | 285.3(V)×190.2(H)mm | 285.3(V)×190.2(H)mm | Same |
| Contrast Ratio | 1800:1 | 1800:1 | Same |
| Scanning<br>frequency (H; V) | 94.94~123.84kHz; 60Hz | 94.94~123.84kHz; 60Hz | Same |
| Recommended<br>Luminance | 300cd/m2 | 500cd/m2 | CP620G is better<br>than CP610 |
| Pixel Pitch | 0.0951×0.0951mm | 0.0951×0.0951mm | Same. |
| Backlight | LED | LED | Same. |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors | Same. |
| Luminance<br>calibration | General calibration sensor | General calibration sensor | Same |
| Video Signal Input | | | |
| Input signals | Type-C×1,<br>Mini DP×1 | Type-C×2<br>HDMI×1 | The difference<br>only shows that<br>they have<br>different input,<br>has nothing to do<br>with the display<br>function. |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Product | JUSHA-CP610 | CP620G LCD Monitor | | | |
| 510(k) Number | K200472 | K230643 | | | |
| 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/Sa<br>ve Mode | 15W / N/A | 20W/NA | The differences caused by components used in the LCD Monitor. This only shows the power consumption is different, nothing to do with the display function | | |
| Power<br>Management | NA | NA | Same | | |
| Miscellaneous Features/Specifications | | | | | |
| USB<br>Ports/standard | upstream (endpoint)/Rev.<br>3.1 | upstream (endpoint)/Rev.<br>3.1 | | | |
| Dimensions w/o<br>stand<br>(W×H×D) | 323mm×225×11.5mm | 312.3mm×220mm×11.5mm | Different housing design due to the different glass size. | | |
| Indication for<br>use | JUSHA-CP610 LCD<br>Monitor is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography | CP620G/CP620 LCD<br>Monitor is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography | CP620G/CP620 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (500 cd/m2), and | | |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Applicable<br>standard | 1 IEC 60601-1:2012, EN<br>60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+<br>C1:2009+A2:2010,<br>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 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>ES60601-1:2005+A1:2012+<br>C1:2009+A2:2010,<br>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 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 | colors, can be<br>used in<br>displaying and<br>viewing digital<br>images for<br>diagnosis of<br>X-ray, MRI and<br>mammography,<br>etc.<br>Same |
| New Features | | | |
| Bidirectional<br>power supply<br>function | / | When one USB-C is<br>connected to the power<br>supply, it can power the<br>CP620 and reverse charge<br>the connected phone or<br>computer through the other<br>USB-C port | This is a new<br>feature of<br>CP620G that<br>makes using the<br>product more<br>convenient and<br>has nothing to do<br>with the display |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| dual-screen<br>display function | / | With two inputs connected,<br>users can have a seamless<br>experience like a traditional<br>6MP medical monitor, two<br>independent 3MP window<br>side by side. | This is a new<br>feature<br>of<br>CP620G<br>that<br>makes using the<br>product<br>more<br>convenient. |
| gravity sensing<br>function | / | With build-in gravity sensor,<br>windows<br>will<br>rotate<br>automatically with<br>the<br>device orientation. | This is a new<br>feature<br>of<br>CP620G<br>that<br>makes using the<br>product<br>more<br>convenient and<br>has nothing to do<br>with the display<br>function. |
| Adaptive<br>environment<br>brightness<br>function | / | CP620G will monitor the<br>ambient light in real time,<br>and change brightness and<br>DICOM<br>compensation<br>accordingly, making it more<br>comfortable to do diagnosis<br>in different<br>lighting<br>environment | This is a new<br>feature<br>of<br>CP620G<br>that<br>makes using the<br>product<br>more<br>convenient. |
| Screen touch<br>function | /…