C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
Device Facts
| Record ID | K222121 |
|---|---|
| Device Name | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor |
| Applicant | Nanjing Jusha Display Technology Co., Ltd. |
| Product Code | PGY · Radiology |
| Decision Date | Sep 19, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
Indications for Use
JUSHA-C630G/JUSHA-C630/C630G/C630 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
The JUSHA-C630G is a 30-inch color TFT LCD medical monitor designed for diagnostic radiology. It accepts digital video input via DisplayPort and displays high-resolution (3280x2048) images with 281.47 trillion colors. The device features built-in DICOM standard Look-Up Tables (LUT), including GAMMA2.2/GAMMA2.4 for the C630G model. It incorporates automated features such as ambient brightness adaptation, real-time DICOM calibration, full-screen brightness equalization, and a presence induction system to optimize display performance. Used in clinical settings by medical practitioners, the monitor assists in the diagnostic interpretation of X-ray and MRI images. The device provides visual output that clinicians use to make diagnostic decisions, potentially improving diagnostic accuracy through consistent, calibrated image presentation.
Clinical Evidence
No clinical data or animal studies were required to support substantial equivalence. Evidence is based on bench testing, including measurements of luminance response, non-uniformity (luminance and chromaticity), small-spot contrast ratio, temporal response, and luminance stability, alongside electrical safety and EMC testing.
Technological Characteristics
30-inch color TFT LCD panel with LED backlight; 3280x2048 resolution; 1050 cd/m² luminance; 1000:1 contrast ratio. Features built-in calibration sensor, ambient light adaptation, and DICOM LUTs. Connectivity via DisplayPort 1.2 and USB 2.0. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).
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 display.
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-C620G (K183492)
Submission Summary (Full Text)
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Nanjing Jusha Display Technology Co., Ltd. Donny Lee Certification Engineer 8A, Block 1, 301 Hanzhongmen Street Nanjing, Jiangsu 210036 China
September 19, 2022
#### Re: K222121
Trade/Device Name: C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: July 18, 2022 Received: July 18, 2022
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
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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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
#### K222121
Device Name C630G/JUSHA-C630G/C630/JUSHA-C630 LCD Monitor
Indications for Use (Describe)
IUSHA-C630G/USHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. 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)
> Prescription Use (Part 21 CFR 801 Subpart D)
[ ] 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: | July 12, 2022 | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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: +86-25- 83305050<br>Fax: +86-25- 58783273 | |
| Device Trade Name: | JUSHA-C630G LCD Monitor, JUSHA-C630 LCD Monitor,<br>C630G LCD Monitor, C630 LCD Monitor | |
| Common/Usual Name: | 6MP Color LCD Monitor | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: | PGY | |
| Predicate Device(s): | JUSHA-C620G; K183492 | |
| Device Description: | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the<br>display system with the high resolution (3280×2048), high luminance<br>(1050 cd/m2), and 281.47 trillion colors, built-in DICOM standard<br>LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT.<br>In addition, C630G has ambient brightness adaptation inside, real-time<br>DICOM automatic calibration, full-screen brightness equalization and<br>presence induction system, therefore this display automatically adjust<br>according to different requirements to achieve the best results.<br>The product is consisted of the following components:<br>- 30" Color TFT LCD Panel<br>- DMX0704AR0/main board/REV:1.1<br>- JUSHA-C630G LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br>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, CFR<br>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-C630G/JUSHA-C630/C630G/C630 LCD Monitor is intended<br>to be used in displaying and viewing digital images for diagnosis of X-<br>ray or MRI, etc. by trained medical practitioners. The device does not<br>support the display of mammography images for diagnosis. | |
| Technology: | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the<br>display system with the high resolution $(3280\times2048)$ , high luminance<br>(1050 cd/m²), and 281.47 trillion colors, built-in DICOM standard<br>LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT.<br>In addition, C630G has ambient brightness adaptation inside, real-time<br>DICOM automatic calibration, full-screen brightness equalization and<br>presence induction system, therefore this display automatically adjust<br>according to different requirements 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, CFR 47 FCC<br>Part15 subpart B: 2017, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic disturbances - Requirements<br>and tests.<br>JUSHA-C630G/ JUSHA-C630/ C630G/ C630 LCD Monitor is<br>substantially equivalent to JUSHA-C620G. Comparison table of the<br>principal characteristics of two devices is shown in the Attachment 1 | |
| | 1. Attachment 1<br>The following quality assurance measures were applied to the development of the system:<br>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:<br>The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence.<br>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 C630G LCD Monitor to be safe and effective, and its 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-C630G LCD Monitor device to the legally marketed predicate JUSHA-C620G LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-<br>C630/C630G/C630 LCD<br>Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Screen<br>technology | 30" Color TFT LCD Panel | 30" Color TFT LCD Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 170°, Vertical<br>170° | Horizontal 170°, Vertical<br>170° | Same |
| Resolution | 3280 x 2048 | 3280 x 2048 | Same |
| Display area | 645.5 (H) x403.0 (V) mm | 645.5(H)×403.0(V)mm | Same |
| Contrast Ratio | 1000:1 | 1000:1 | Same |
| Recommended<br>Luminance | 500cd/m² | 500cd/m² | Same |
| Pixel Pitch | 0.197x0.197 mm | 0.197×0.197mm | Same |
| Backlight | LED | LED | Same |
| Display Colors | 16-bit, 281.47 trillion colors | 16-bit, 281.47 trillion colors | Same |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Video Signal Output | | | |
| Output signals | DisplayPort x 1 | DisplayPort x 1 | Same |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| | | | |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-<br>C630/C630G/C630 LCD<br>Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Power<br>Requirement | AC 100~240V 50~60Hz | 24V DC | The differences<br>caused by<br>components used<br>in the LCD<br>Monitor. This<br>only shows the<br>power<br>requirement is<br>different, not<br>raising different<br>questions of its<br>safety and<br>effectiveness. |
| Power<br>Consumption/Sa<br>ve Mode | 150W/less than 0.5W | 150W/less than 0.5W | Same |
| Power<br>Management | DVI DMPM | DVI DMPM | Same |
| | DisplayPort 1.1a | DisplayPort 1.2 | |
| 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 |
| Dimensions w/o | Without stand: | Without stand: | Different |
| stand | | | housing design |
| (W x H x D) | 721.5mm×493.5mm×<br>110mm | 705mm×477mm×77mm<br>With stand: | which has<br>nothing to do<br>with the display |
| | With stand:<br>721.5mm×585mm×<br>262mm | 705mm×567mm×262mm | function. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-<br>C630/C630G/C630 LCD<br>Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Indication for<br>use | JUSHA-C620G LCD<br>Monitor is intended to be<br>used in displaying and<br>viewing digital images for<br>diagnosis of X-ray or MRI,<br>etc. by trained medical<br>practitioners. The device<br>does not support the display<br>of mammography images for<br>diagnosis. | JUSHA-C630G LCD<br>Monitor is intended to be<br>used in displaying and<br>viewing digital images for<br>diagnosis of X-ray or MRI,<br>etc. by trained medical<br>practitioners. The device<br>does not support the display<br>of mammography images for<br>diagnosis. | Same |
| 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 performance.<br><br>2 IEC 60601-1-2 Edition<br>4:2014, EN 60601-1-2:2015,<br>CFR 47 FCC Part15 subpart<br>B: 2017, Medical electrical<br>equipment - Part 1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral standard:<br>Electromagnetic disturbances | 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 performance.<br><br>2 IEC 60601-1-2 Edition<br>4:2014, EN 60601-1-2:2015,<br>CFR 47 FCC Part15 subpart<br>B: 2017, Medical electrical<br>equipment - Part 1-2: General<br>requirements for basic safety<br>and essential performance -<br>Collateral standard:<br>Electromagnetic disturbances | Same |
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## PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
### Bench testing:
Bench testing was conducted to demonstrate the JUSHA-C630G 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 TG18 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
- . Performance data on luminance stability
### Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JUSHA-C630G 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, JUSHA-C630G, does not require animal or clinical studies to support substantial equivalence.
### CONCLUSIONS
#### JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor.
or 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 JUSHA-C630G Medical Display does not raise any new issues of safety or effectiveness.
