JUSHA-C43 LCD Monitor

K151972 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Sep 10, 2015 · Radiology

Device Facts

• Record ID: K151972
• Device Name: JUSHA-C43 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Sep 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-C43 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

JUSHA-C43 is a 30-inch color active matrix TFT LCD monitor; provides high-resolution (2560 x 1600) visual output for medical imaging. Device receives digital image data via DVI/DisplayPort inputs; utilizes internal DICOM look-up tables to ensure accurate grayscale and color representation. Operated by trained medical practitioners in clinical environments; provides visual display for review and analysis of medical images. Built-in calibration sensor maintains luminance stability. Output assists clinicians in diagnostic review; excludes mammography. Benefits include high-resolution visualization of medical data to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical or animal studies conducted. Bench testing included measurement of angular dependency of luminance, luminance/chromaticity non-uniformity (per TG18 guidelines), 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

30-inch color active matrix TFT LCD; 2560 x 1600 resolution; 350cd/m² luminance; 12-bit color depth (68.7 billion colors); 1024 simultaneous shades of gray. Connectivity: DVI-D, DisplayPort. Features built-in calibration sensor. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images for review and analysis. Not for mammography 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

• RADIFORCE RX440 (K130070)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2015

Nanjing Jusha Display Technology Co., Ltd. % Ma Jing Certification Engineer 301 Hnazhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing Jiangsu 210036 CHINA

Re: K151972

Trade/Device Name: JUSHA-C43 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 16, 2015 Received: July 16, 2015

Dear Ma Jing:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

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

Enclosure

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# Indications for Use

510(k) Number (if known) K151972

Device Name JUSHA-C43 LCD Monitor

Indications for Use (Describe)

JUSHA-C43 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)

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

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

| Date: | Jun,15,2015 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd<br>Add: 301, Hanzhongmen Street, 8F Block A, No.1, Nanjing<br>International Service Outsourcing Mansion, Nanjing, 210036 China |
| Contact Person: | Ma Jing<br>Certification Engineer<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-C43 LCD Monitor |
| Common/Usual Name: | 4MP Color LCD Monitor |
| Classification Name: | System, image processing ,Radiology |
| Product Code: | PGY |
| Predicate Device(s): | RADIFORCE RX440;K130070 |
| Device Description: | JUSHA-C43 LCD Monitoris the display system with the high<br>resolution(2560 x 1600), high luminance(350cd/m²) and 1024<br>simultaneous shades of gray out of a palette of 4096, 4 DICOM<br>look up table inside, the product is consisted of the following<br>components:<br>- 30inch, Color Active Matrix Liquid Crystal Display<br>- FR4-v0.4 |
| - JUSHA-C43 LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br><br>The LCD Monitoris designed, tested, and will be manufactured<br>in accordance with both mandatory and voluntary standards:<br>1. IEC 60601-1Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic<br>safety and essential performance 2005 + CORR. 1<br>(2006) +CORR. 2 (2007)<br>2. IEC 60601-1-2 Edition 3:2007, medical electrical<br>equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility -<br>Requirements and tests. | |
| Intended Use: | JUSHA-C43 LCD Monitoris intended to be used in displaying<br>and viewing digital images for review and analysis by trained<br>medical practitioners. It does not support the display of<br>mammography images for diagnosis. |
| Technology: | JUSHA-C43 LCD Monitor is the display system with the high<br>resolution monitor (4 megapixels) with electronic capabilities for<br>evaluation of high resolution medical images, high<br>luminance(350cd/m²) and 1024 simultaneous shades of gray<br>out of a palette of 4096, 4 DICOM look up table inside |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The LCD Monitor complies with voluntary standards as<br>following:<br>1 IEC 60601-1Medical equipment medical electrical |

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| | require clinical studies to support substantial equivalence.<br>The proposed device is Substantially Equivalent (SE) to the<br>predicate device which is US legally market device. Therefore,<br>the subject device is determined as safe and effectiveness. |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the<br>JUSHA-C43 LCD Monitor to be as safe as effective, and<br>performance is substantially equivalent to the predicate<br>device(s). |

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This comparison identifies the similarities and differences of the proposed JUSHA-C43 LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX440 LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------------------|----------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 29.8" Color TFT LCD<br>Panel | 30", Color Active Matrix<br>TFT LCD Panel | The panel of<br>JUSHA-C43 is larger<br>than the predicate<br>device, it can display<br>more<br>information |
| Viewing angle<br>(H, V) | Horizontal 176°,Vertical<br>176° | Horizontal 178°,Vertical<br>178°(CR > 10) | The viewing angle of<br>JUSHA-C43 is wider<br>than the predicate<br>device, it can get<br>greater field of view |
| Resolution | 2560 x1600/1280 x1600<br>x2 | 2560 x 1600/1280 x 1600<br>x2 | Same |
| Display area | 641.2(H) x 400.8 (V) mm | 641.28 (H) x 400.8 (V) mm | Same |
| Recommended<br>Luminance | 300cd/m² | 300cd/m² | Same |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Contrast Ratio | 1100:1 | 1200:1 | The contrast ratio of<br>JUSHA-C43 is higher<br>than the predicate<br>device, it can display<br>image more clarity |
| Scanning<br>frequency (H; V) | 31 - 159 kHz / 29 - 61 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 59 - 61 Hz, 29.5 -<br>30.5 Hz | 103.8kHz;50Hz | The two differences<br>between the two<br>device is caused by<br>the different no<br>display area defined<br>by different<br>manufacturers, but<br>the display area is<br>same(2048*2560),so<br>the same picture<br>displayed on the two<br>devices has the same<br>effect |
| Dot clock | 152MHz | 148MHz | by different<br>manufacturers, but<br>the display area is<br>same(2048*2560),so<br>the same picture<br>displayed on the two<br>devices has the same<br>effect |
| Pixel Pitch | 0.2505 x 0.2505 mm | 0.2505 x 0.2505 mm | Same |
| Backlighting | LED | LED | Same |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|-----------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit , 68.7billion colors | The JUSHA-C43 LCD<br>Monitor uses a color<br>extension technology<br>to improve image<br>display quality |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Video Signal Input | | | |
| Input signals | DVI standard 1.0 | DVI standard 1.0 | Same |
| Input<br>terminational | DVI-D (dual link) x 1,<br>DVI-D (single link) x 1,<br>DisplayPort x 1 | DVI-D (dual link) x 1,<br>DVI-D (single link) 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 - 120 V, 200 - 240<br>V: 50 / 60 Hz | AC 100-240V 50-60Hz | same |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|----------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Power<br>Consumptions/Save Mode | 84W/less than 0.7W | 82W/less than1.5W | The differences<br>caused by different<br>adapter and<br>components used in<br>the LCD Monitor, the<br>JUSHA-C43 has<br>fewer power<br>consumptions, this<br>only shows the power<br>consumption is<br>different, nothing to<br>do with the display<br>function |
| Power<br>Management | DVI DMPM, DisplayPort<br>1.1a | DVI DMPM, DisplayPort<br>1.1a | Same |
| Miscellaneous Features/Specifications | | | |
| USB<br>Ports/standard | 1 upstream ,<br>2 downstream/ Rev. 2.0 | 1 upstream (endpoint), 2<br>downstream/ Rev. 2.0 | Same |
| Dimensions w/o<br>stand<br>(W x H x D) | Without stand:<br>702x108x473 mm | With stand:<br>692x252x523mm<br>Without stand:<br>692x87x453mm | Different housing<br>design due to the<br>different panel size. |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Indication for use | RADIFORCE RX440 is<br>intended to be used in<br>displaying and viewing<br>digital images for review<br>and analysis by trained<br>medical practitioners. It<br>does not support the<br>display of mammography<br>images for diagnosis. | JUSHA-C43 LCD Monitor<br>is intended to be used in<br>displaying and viewing<br>digital images for review<br>and analysis by trained<br>medical practitioners. It<br>does not support the<br>display of mammography<br>images for diagnosis. | Same |

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| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Applicable<br>standard | 1 IEC 60601-1Medical<br>equipment medical<br>electrical equipment - Part<br>1: General requirements<br>for basic safety and<br>essential performance<br>1988+A1 : 1991 +<br>A2:1995<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 -<br>Requirements and tests. | 1 IEC 60601-1Medical<br>equipment medical<br>electrical equipment - Part<br>1: General requirements<br>for basic safety and<br>essential performance<br>IEC 60601-1:2005 +<br>CORR. 1 (2006) +CORR. 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 -<br>Requirements and tests. | The JUSHA-C43<br>safety standard is<br>edition 3.0,<br>RADIFORCE RX440<br>safety standard is<br>edition 2.0. nothing to<br>do with the display<br>function |

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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-C43 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 TGI18 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-C43. 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-C43, does not require animal or clinical studies to support substantial equivalence.

# CONCLUSIONS

JUSHA-C43 Medical Display 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 should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-C43 Medical Display does not raise any new issues of safety or effectiveness.