JUSHA-M52C MEDICAL DISPLAY

K131390 · Nanjing Jusha Display Technology Co., Ltd. · LLZ · Nov 27, 2013 · Radiology

Device Facts

• Record ID: K131390
• Device Name: JUSHA-M52C MEDICAL DISPLAY
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Nov 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M52C Medical Display is intended to be used by trained physicians in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

Device Story

JUSHA-M52C is a 21.3-inch monochrome TFT LCD medical display system. It accepts digital image data as input and transforms it for high-resolution visualization. Key specifications include 2048 x 2560 resolution, 700 cd/m² luminance, and 256 simultaneous gray shades from a 4096-palette, supported by an internal DICOM look-up table. Used in clinical settings by physicians to evaluate high-resolution medical images, including digital mammography. The device assists clinicians in diagnostic decision-making by providing standardized, high-fidelity image rendering. Components include the display monitor, motherboard (HDVI-3M V1.0), power adapter, and data cables.

Clinical Evidence

No clinical data. Substantial equivalence was supported by non-clinical bench testing, including safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

21.3-inch monochrome TFT LCD; 2048 x 2560 resolution; 700 cd/m² luminance; 256 gray shades from 4096 palette; internal DICOM look-up table; motherboard HDVI-3M V1.0; compliant with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for use by trained physicians for viewing medical images, including digital mammography, in systems where the display meets manufacturer-specified performance requirements.

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 G51 (K042755)

Submission Summary (Full Text)

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K131390
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510(k) Premarket Notification Submission

# 510(k) Summary

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

| Date: | April 21,2013 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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<br>China | |
| Primary Contact Person: | Mike Gu<br>Regulatory Manager<br>Guangzhou Osmunda Medical Device Consulting Co., Ltd<br>Tel: [phone]<br>Fax: [phone] | |
| Secondary Contact<br>Person: | Zhu chengshun<br>Quality Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] | NOV 27 2013 |
| Device Trade Name: | JUSHA-M52C Medical Display | |
| Common/Usual Name: | Image display system, medical image workstation, image<br>monitor/display, and others | |
| Classification Name:<br>Product Code: | System, image processing 21CFR 892.2050<br>90LLZ | |
| Predicate Device(s): | RADIFORCE G51:K042755 | |
| Device Description: | JUSHA-M52C Medical Display is the display system with<br>the high resolution(2048 x 2560), high luminance(700<br>cd/m²), and 256 simultaneous shades of gray out of a palette<br>of 4096, 8 DICOM look up table inside, the product is<br>consisted of the following components:<br>- 21.3 inch, mono-TFT Liquid Crystal Display<br>- Motherboard HDVI-3M V1.0<br>- JUSHA-M52C Medical Display software<br>- Power Adapter<br>- Data Cable.<br>The Medical Display is designed, tested, and will be<br>manufactured in accordance with both mandatory and<br>voluntary standards:<br>1. IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential | |
| performance 1988+A1 : 1991 + A2:1995 | | |
| 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-M52C Medical Display is intended to be used by<br>trained physicians in various kinds of medical image<br>applications including digital mammography system for<br>which the device complies with the performance specified by<br>the manufacturer of the system. | |
| Technology: | JUSHA-M52C Medical Display is the display system with<br>the high resolution monitor (5 megapixels) with electronic<br>capabilities for evaluation of high resolution medical images,<br>high luminance (700 cd/m²) and 256 simultaneous shades of<br>gray out of a palette of 4096, 8 DICOM look up table inside | |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The Medical Display complies with voluntary standards as<br>following:<br>1 IEC 60601-1 Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic safety<br>and essential performance 1988+A1 : 1991 + A2:1995<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.<br>JUSHA-M52C is substantially equivalent to RadiForce G51.<br>G51. M52C employs the maximum resolution values same as<br>that of RadiForce G51. Comparison table of the principal<br>characteristics of 2 devices is shown in the Attachment 1. | |
| | Attachment 1<br>The following quality assurance measures were applied to<br>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) | |
| (k) Premarket Notification Submission | | |
| | • Safety testing (Verification)<br>Summary of Clinical Tests:<br>The subject of this premarket submission, Medical Display, 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 the JUSHA-M52C Medical Display to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | |

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510(k

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and the comments of the comments of the comments of

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure with outstretched arms, with three curved lines above it.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

November 27, 2013

Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd. 710 Floor, 982 Congyun Road Baiyun District Guangzhou, Guangdong 510420 CHINA

Re: K131390

Trade/Device Name: JUSHA-M52C Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 24, 2013 Received: September 30, 2013

Dear Mr. Gu:

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 r ou may more or ovisions 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Gu

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcessiorYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Sm. 7)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K131390

#### Device Name JUSHA-M52C Medical Display

#### Indications for Use (Describe)

JUSHA-MS2C Medical Display is intended to be used by trained physicians in various kinds of medical including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PKC Palishing Seringer ( U1) 1 4614.741 ម