JUSHA-C23C LCD Monitor

K151861 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Sep 10, 2015 · Radiology

Device Facts

• Record ID: K151861
• Device Name: JUSHA-C23C 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-C23C 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-C23C is a 2MP color LCD monitor for diagnostic medical imaging. Input: digital image signals via DVI or DisplayPort. Processing: internal 12-bit DICOM LUT and 3 GAMMA LUTs; automatic signal identification (gray vs. color) via CGA function; ambient brightness adaptation; presence induction. Output: high-resolution (1600x1200) medical images. Used in clinical settings by radiologists/physicians to view diagnostic images; aids clinical decision-making by providing calibrated, high-contrast visualization of patient anatomy. Benefits: improved image clarity and diagnostic accuracy through grayscale expansion and automated luminance adjustment.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via measurement of angular luminance dependency, luminance/chromaticity non-uniformity (TG18 guidelines), small-spot contrast ratio, temporal response, and luminance stability. Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

21.3-inch Color-TFT LCD panel; 1600x1200 resolution; 600cd/m² luminance; 12-bit DICOM LUT (4096 shades); LED backlight; ambient brightness sensor; presence induction system. Connectivity: DVI-D, DisplayPort 1.1a, USB 2.0. Standards: IEC 60601-1, IEC 60601-1-2. Software: embedded firmware for LUT management and signal identification.

Indications for Use

Indicated for trained medical practitioners to display and view digital diagnostic images (e.g., X-ray, 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

• RADIFORCE RX240 (K113844)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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: K151861

Trade/Device Name: JUSHA-C23C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 13, 2015 Received: August 17, 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 Oals

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) K151861

Device Name JUSHA-C23C LCD Monitor

Indications for Use (Describe)

JUSHA-C23C LCD Monitor is intended to be used in displaying 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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: | May 6, 2014 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Ma Jing |
| | Certification Engineer |
| | Nanjing Jusha Display Technology Co., Ltd |
| | Tel: [phone] |
| | Add: 8A, Block 1. Nanjing International Service Outsourcing<br>Mansion, No. 301, Hanzhongmen street, Nanjing, China. |
| | Fax: [phone] |
| Device Trade Name: | JUSHA-C23C LCD Monitor |
| Common/Usual Name: | 2MP Color LCD Monitor |
| Classification Name: Product | System, image processing 21CFR 892.2050 |
| Code: | PGY |
| Predicate Device(s): | RADIFORCE RX240; K113844 |
| Device Description: | JUSHA-C23C LCD Monitor is the display system with the high<br>resolution (1600*1200), high luminance 600cd/m²), and 1024<br>simultaneous shades of gray out of a palette of 4096, 8 DICOM look<br>up table and 3 GAMMA look up table inside. JUSHA-C23C has |
| | ambient brightness adapting and presence induction system, with<br>these this display can automatic adjustment according to different<br>requirements in order to achieve the best results. |
| | The product is consisted of the following components: |
| | - 21.3inches, Color-TFT LCD Panel |
| | - JUSHA-SMS_19inch motherboard/FR-4/REV:0.1 |
| | - JUSHA-C23C LCD Monitor software |
| | - Power Adapter |
| | - Data Cable |
| | The LCD Monitor is designed, tested, and will be manufactured in<br>accordance with both mandatory and voluntary standards:<br><br>1. IEC 60601-1Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic safety<br>and essential performance<br>2005+CORR.1(2006)+CORR.2(2007)<br>2. IEC 60601-1-2 Edition 3:2007, Medical electrical<br>equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests. |
| Intended Use: | JUSHA-C23C 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-C23C LCD Monitor is the display system with the high<br>resolution monitor (2 megapixels) with electronic capabilities for<br>evaluation of high resolution medical images, high luminance (600<br>cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,<br>8 DICOM look up table and 3 GAMMA look up table inside. In<br>particular, JUSHA-C23C LCD Monitor contains CGA function, it is<br>specially made by JUSHA, it can automatic identify gray and color<br>signals, then gray area calls DICOM LUT and color area calls<br>GAMMA2.2 LUT. JUSHA-C23C has ambient brightness adapting<br>and presence induction system, with these this display can automatic<br>adjustment according to different requirements in order to achieve the<br>best results. |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br><br>The LCD Monitor complies with voluntary standards as following:<br><br>1 IEC 60601-1Medical equipment medical electrical equipment -<br>Part 1: General requirements for basic safety and essential<br>performance 2005+CORR.1(2006)+CORR.2(2007)<br>2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic compatibility<br>- Requirements and tests.<br><br>JUSHA-C23C is substantially equivalent to RADIFORCE RX240.<br>JUSHA-C23C employs the maximum resolution values same as that<br>of RADIFORCE RX240. Comparison table of the principal<br>characteristics of 2 devices is shown in the Attachment 1 |
| | Attachment 1 |
| | The following quality assurance measures were applied to the |
| | 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 |
| | require clinical studies to support substantial equivalence. |
| | 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 the |
| | JUSHA-C23C LCD Monitor to be as safe, as effective, and |
| | 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-C23C LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX240 LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | | | |
| | | | 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 176° ;Vertical<br>176° | Same | |
| 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 | 1200:1 | 1400:1 | Due to the<br>different panel. | |
| Scanning<br>frequency (H; V) | 31~100 kHz;59~61Hz | 52~76 kHz;59~61Hz | 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 | 400cd/m² | Same | |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same. | |
| Backlight | LED | LED | Same | |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | | |
| 510(k) Number | K113844 | / | | |
| DICOM LUT | 10-bit (Display Port) : 1024 | 12-bit:4096 | The<br>JUSHA-C23C<br>LCD Monitor<br>uses a grayscale<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. | |
| | | | | |
| | 8-bit: 256 | | | |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | | |
| | | | | |
| Video Signal Input | | | | |
| Input signals | DVI standard 1.0, | DVI standard 1.0, | | |
| | DisplayPort 1.1a | DisplayPort 1.1a | | |
| Input<br>terminational | DVI-D x 1, | DVI-D x 1, | | |
| | DisplayPort x 1 | DisplayPort x 1 | | |
| Display<br>controller | Off the shelf | Off the shelf | | |
| | | | | |
| Power Related Specification | | |…