JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor

K183498 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Feb 5, 2019 · Radiology

Device Facts

• Record ID: K183498
• Device Name: JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Feb 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-C270G/JUSHA-C270/C270G/C270 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

LCD monitor system for diagnostic radiology; displays digital images (X-ray, MRI) for clinician review. Input: digital image data via DVI-D or DisplayPort. Operation: high-resolution (1600x1200) color TFT LCD panel; features ambient brightness adaptation, real-time DICOM automatic calibration, and presence induction system for optimized viewing. Output: visual display of medical images. Used in clinical settings by medical practitioners. Benefits: provides high-fidelity, calibrated visualization of diagnostic images to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical or animal studies required for substantial equivalence.

Technological Characteristics

21.3" Color TFT LCD panel; 1600x1200 resolution; 600 cd/m² luminance; 1400:1 contrast ratio; 16-bit color depth. Features: ambient brightness sensor, presence induction, built-in DICOM LUT, and calibration sensor. Connectivity: DVI-D, DisplayPort, USB 2.0. Standards: IEC 60601-1 (safety), 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-C23C (K151861)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.

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

February 5, 2019

### Re: K183498

Trade/Device Name: JUSHA-C270G/ JUSHA-C270/C270G/C270 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2019 Received: January 11, 2019

#### Dear 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

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bages

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K183498

Device Name

JUSHA-C270G/JUSHA=C270/C270G/C270 LCD Monitor

Indications for Use (Describe)

JUSHA-C270G/JUSHA-C270/C270G/C270 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> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K183498

# 510(k) Summary

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

| Date: | December 5, 2018 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Zilong Liang<br>Certification Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor |
| Common/Usual Name: | 2MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | JUSHA-C23C; K151861 |
| Device Description: | JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the<br>display system with the high resolution (1600*1200), high luminance<br>(600 cd/m²), and 281.47 trillion colors, built-in DICOM standard<br>LUT. In particular, JUSHA-C270G has ambient brightness adapting,<br>real-time DICOM automatic calibration and presence induction<br>system, with these this display can automatic adjustment according to<br>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>- DMX0302CR0/main board/V1.2<br>- JUSHA-C270G 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:<br>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>CFR 47 FCC Part15 subpart B: 2017, Medical electrical<br>equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard: |
| Intended Use: | JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is intended<br>to be used in displaying and viewing digital images for diagnosis of<br>X-ray or MRI, etc. by trained medical practitioners. The device does<br>not support the display of mammography images for diagnosis. |
| Technology: | JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the<br>display system with the high resolution (1600*1200), high luminance<br>(600 cd/m2), and 281.47 trillion colors, built-in DICOM standard<br>LUT. In particular, JUSHA-C270G has ambient brightness adapting,<br>real-time DICOM automatic calibration and presence induction<br>system, with these this display can automatic adjustment according to<br>different requirements in order 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<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, CFR 47<br>FCC Part15 subpart B: 2017, Medical electrical equipment - Part<br>1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic disturbances -<br>Requirements and tests.<br>JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is<br>substantially equivalent to JUSHA-C23C.<br>JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor employs<br>the maximum resolution values same as that of JUSHA-C23C.<br>Comparison table of the principal characteristics of 2 devices is<br>shown in the Attachment 1.<br>Attachment 1<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) |
| | 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<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>JUSHA-C270G LCD Monitor to be as safe, as effective, and<br>performance is substantially equivalent to the predicate device(s). |

{4}------------------------------------------------

{5}------------------------------------------------

## 12.1 Product Comparison

This comparison identifies the similarities and differences of the proposed JUSHA-C270G LCD Monitor device to the legally marketed predicate JUSHA-C33C LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27<br>0/C270G/C270 LCD<br>Monitor | |
| 510(k) Number | K151861 | / | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle<br>(H, V) | Horizontal 176°, Vertical<br>176° | Horizontal 178°, Vertical<br>178° | - |
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 | Same |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm | Same |
| Contrast Ratio | 1400:1 | 1400:1 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27<br>0/C270G/C270 LCD<br>Monitor | |
| 510(k) Number | K151861 | / | |
| Scanning<br>frequency (H; V) | 52~76 kHz;59~61Hz | 37.9~75kHz;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 | 350cd/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 | 0.27x0.27 mm | 0.27x0.27 mm | Same |
| Backlight | LED | LED | Same. |
| Display Colors | 12-bit | 16-bit | The<br>JUSHA-C270G<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. |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27<br>0/C270G/C270 LCD<br>Monitor | |
| 510(k) Number | K151861 | / | |
| Input signals | DVI-D x 1,<br>DisplayPort x 1 | DVI-D x 1,<br>DisplayPort x 1 | same |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | AC 100~240V 50~60Hz | DC 24V | - |
| Power<br>Consumption/Sa<br>ve Mode | 65W/less than 2.5W | 50W/less than 0.5W | 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 | DVI DMPM | DVI DMPM | Same |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | |
| Miscellaneous Features/Specifications | | | |
| USB | 1 upstream (endpoint), | 1 upstream (endpoint), | Same |
| Ports/standard | 2 downstream/ Rev. 2.0 | 2 downstream/ Rev. 2.0 | |
| Dimensions w/o | Without stand:<br>382mm x490mm x75mm | Without stand:<br>382mm x490mm x77mm | Different |
| stand | With stand:<br>382mm x533mm x238mm | With stand:<br>382mm x635mm x238mm | housing design |
| (W x H x D) | | | due to the<br>different panel<br>size. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27<br>0/C270G/C270 LCD<br>Monitor | |
| 510(k) Number | K151861 | / | |
| Indication for<br>use | JUSHA-C23C LCD Monitor<br>is intended to be used in<br>displaying and viewing<br>digital images for diagnosis<br>of X-ray or MRI, etc. by<br>trained medical practitioners.<br>The device does not support<br>the display of mammography<br>images for diagnosis. | JUSHA-C270G 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 60601-1Medical<br>equipment medical electrical<br>equipment - Part 1: General<br>requirements for basic safety<br>and essential performance<br>2005+CORR.1(2006)+COR<br>R.2(2007)<br>2 IEC 60601-1-2 Edition<br>3:2007, Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements<br>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>CFR 47 FCC Part15 subpart<br>B: 2017, Medical electrical<br>equipment - Part 1-2:<br>G…