JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor

K230728 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Jun 9, 2023 · Radiology

Device Facts

• Record ID: K230728
• Device Name: JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Jun 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

C660G/C810G 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-C660G/C660/C810G LCD monitors are high-resolution display systems for medical imaging. Inputs include digital image data from medical imaging modalities (X-ray, MRI) via DisplayPort, DVI, or Type-C interfaces. The device transforms these inputs into high-luminance, grayscale-calibrated visual outputs using built-in DICOM standard Look-Up Tables (LUTs). Features include ambient brightness adaptation, real-time DICOM automatic calibration, full-screen brightness equalization, and presence induction to optimize display performance. Used in clinical environments by trained medical practitioners to view diagnostic images; the output assists clinicians in interpreting medical images for diagnosis. The device benefits patients by providing high-fidelity, consistent, and calibrated image visualization for accurate clinical decision-making.

Clinical Evidence

No clinical data or animal studies were required or provided. Substantial equivalence is supported by bench testing, including measurement of luminance response, luminance/chromaticity non-uniformity (per TG18 guidelines), temporal response, and luminance stability, alongside electrical safety and EMC testing.

Technological Characteristics

Color-TFT LCD panels with LED backlights. C660G: 3280x2048 resolution, 16-bit LUT. C810G: 3840x2160 resolution, 14-bit LUT. Features: ambient brightness adaptation, real-time DICOM auto-calibration, full-screen brightness equalization, presence induction. Connectivity: DisplayPort 1.2a, DVI, Type-C, USB 2.0. Standards: IEC 60601-1, IEC 60601-1-2. Standalone display system.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for the diagnosis of X-ray or MRI. Not indicated 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

• C630G LCD Monitor (K222121)

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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

June 9, 2023

### Re: K230728

Trade/Device Name: JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA- C660G/C660/C660G 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.

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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/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.

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) K230728

#### Device Name

JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor

Indications for Use (Describe)

C660G/C810G LCD Monitor is intended to be used in displaying digital images 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) | |
|-------------------------------------------------|--|
| | |

|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

# (K230728)

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

| Date: | Mar 16, 2023 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd<br>Add: 8A, Block 1. Nanjing International Service Outsourcing<br>Mansion, No. 301, Hanzhongmen street, Nanjing City, Jiangsu<br>Province, 210036 China. |
| Contact Person: | Donny Lee<br>Certification Engineer<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device Trade Name: | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-<br>C660G/C660/C660G LCD Monitor |
| Common/Usual Name: | 6MP/8MP Color LCD Monitor |
| Classification Name: | Medical Image Management and Processing System 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | C630G, K222121 |
| Device Description: | JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the<br>display system with high resolution (3280×2048), high luminance (800<br>cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard<br>LUT. In particular, C660G has ambient brightness adaptation inside,<br>on top of which C660G has real-time DICOM automatic calibration,<br>full-screen brightness equalization and presence induction system,<br>therefore this display automatically adjust according to different<br>requirements to achieve the best results.<br><br>The product is consisted of the following components:<br>- the display with stand<br>- a graphic card |
| | - agraphic card driver CD |
| | - an AC power cable |
| | - an external power supply |
| | - a Type-C cable |
| | - Three DP cables |
| | - a USB cable |
| | JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results. |
| | The product is consisted of the following components: |
| | - the display with stand |
| | - a graphic card |
| | - agraphic card driver CD |
| | - an AC power cable |
| | - an external power supply |
| | - a DVI cable |
| | - two Mini DP switch to DP cable |
| | - a USB cable |
| | |
| | The LCD Monitors are designed, tested, and will be manufactured in 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>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: | C660G/C810G LCD Monitor is intended to be used in displaying and<br>viewing digital images for diagnosis of X-ray or MRI, etc. by trained<br>medical practitioners. The device does not support the display of<br>mammography images for diagnosis. |
| Technology: | JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the<br>display system with high resolution (3280×2048), high luminance (800<br>cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard<br>LUT. In particular, C660G has ambient brightness adaptation inside,<br>on top of which C660G has real-time DICOM automatic calibration,<br>full-screen brightness equalization and presence induction system,<br>therefore this display automatically adjust according to different<br>requirements to achieve the best results.<br>JUSHA-C810G/ C810G LCD Monitor is the display system with high<br>resolution (3840×2160), high luminance (800 cd/m2), and 14-bit<br>grayscale (16384 grayscale), built-in DICOM standard LUT. In<br>particular, C810G has ambient brightness adaptation inside, on top of<br>which C810G has real-time DICOM automatic calibration, full-screen<br>brightness equalization and presence induction system, therefore this<br>display automatically adjust according to different requirements<br>to<br>achieve the best results. |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The LCD Monitor(C660G,C810G) complies with voluntary standards<br>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. |
| 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:<br>Electromagnetic disturbances - Requirements and tests |
| | C660G/C810G LCD Monitor are substantially equivalent to C630<br>LCD Monitor. They have equivalent characteristics andfunctions<br>according to comparison table, pleaserefer to 12. Product Comparison |
| | 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<br>require clinical studies to support substantial equivalence. |
| | 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>C660G/C810G LCD Monitor to be as safe, as effective, and<br>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 C660G/C810G LCD Monitor device to the legally marketed predicate C630 LCD Monitor device to which substantial equivalency is claimed.

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| Attributes | Predicate Device | Proposed Device | | Discussion of Differences |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | | |
| Product | C630G LCD<br>Monitor | C660G LCD<br>Monitor | C810G LCD<br>Monitor | |
| 510(k) Number | K222121 | K230728 | | |
| Screen<br>technology | 30 inches, Color-TFT LCD Panel | 30inches,Color-TFT LCD Panel | 31.5inches,<br>Color-TFT LCD<br>Panel | C660G and<br>C630G are<br>same, C810G is<br>larger than<br>C630G. |
| Viewing angle<br>(H, V) | Horizontal<br>178°, Vertical<br>178° | Horizontal<br>178°, Vertical 178° | Horizontal<br>178°, Vertical<br>178° | Same |
| Resolution | 3280x2048 | 3280x2048 | 3840x2160 | C660G and<br>C630G are<br>same, C810G is<br>better than<br>C630G. |
| Display area | 645.5 (H) mm ×<br>403 (V)mm | 645.5 (H) mm ×<br>409.3 (V)mm | 697.31(H) mm×<br>392.23(V)mm | C660G and<br>C630G are<br>same, C810G is<br>larger than<br>C630G. |
| Contrast Ratio | 1000:1 | 2000:1 | 1300:1 | C660G and<br>C810G are larger<br>than C630G. |
| DICOM<br>calibrated<br>luminance | 500cd/m² | 800 cd/m² | 1000cd/m² | C660G and<br>C810G are larger<br>than C630G. |
| Pixel Pitch | 0.197mm×<br>0.197mm | 0.197mm×<br>0.197mm | 0.1816mm×<br>0.1816mm | C660G and<br>C630G are<br>same, C810G is<br>better than<br>C630G. |
| Backlight | LED | LED | LED | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
| Product | C630G LCD<br>Monitor | C660G LCD<br>Monitor | C810G LCD<br>Monitor | |
| 510(k) Number | K222121 | K230728 | | |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | 14-bit:16384 | This parameter is an output<br>range.C810G is smaller than<br>them, But the three products<br>can only output 10bit images. |
| Luminance<br>calibration | Built in<br>calibration<br>sensor provided | Built in calibration<br>sensor provided | Built in<br>calibration<br>sensor provided | Same. |
| Video Signal Input | | | | |
| Input signals | DisplayPort 1.2a<br>DVI | DisplayPort 1.2a<br>Type-C<br>DVI | DisplayPort 1.2a<br>DVI | The difference<br>only shows that<br>they have<br>different<br>input,has nothing<br>to do with the<br>display function. |
| Input<br>terminational | DisplayPort×2<br>DVI×1 | DisplayPort×2<br>Type-C<br>DVI×1 | DisplayPort×2<br>DVI×1 | The difference<br>only shows that<br>they have<br>different<br>input,has nothing<br>to do with the<br>display function. |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | NA | C660G and<br>C630G are<br>same, C810G<br>has no output<br>interface. |
| Output<br>Terminational | DisplayPort×1 | DisplayPort×1…