JUSHA-M32 MEDICAL DISPLAY

K131391 · Nanjing Jusha Display Technology Co., Ltd. · LLZ · Aug 21, 2013 · Radiology

Device Facts

• Record ID: K131391
• Device Name: JUSHA-M32 MEDICAL DISPLAY
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M32 Medical Display 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 is not specified for digital mammography system.

Device Story

JUSHA-M32 is a 21.3-inch mono-TFT liquid crystal medical display system. It accepts digital image inputs for visualization by trained medical practitioners in clinical settings. The device features a 2048 x 1536 resolution, 700 cd/m² luminance, and supports 256 simultaneous shades of gray from a 4096-shade palette. It incorporates an internal DICOM look-up table to ensure accurate grayscale rendering. The system includes the display monitor, motherboard (HDVI-3M V1.0), power adapter, data cable, and proprietary software. By providing high-resolution, DICOM-compliant visualization of diagnostic images (X-ray, MRI), the device assists clinicians in image interpretation and diagnostic decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including performance verification, safety testing, and compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

21.3-inch mono-TFT LCD; 2048 x 1536 resolution; 700 cd/m² luminance; 256/4096 grayscale palette; internal DICOM look-up table. Components: Motherboard HDVI-3M V1.0, power adapter, data cable. 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 the diagnosis of X-ray or MRI. Not indicated for digital mammography systems.

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 GS310 (K060845)

Submission Summary (Full Text)

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#### 510(k) Premarket Notification Submission

# AUG 2 1 2013

# 510(k) Summary

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

| Date: | Mar, 11,2013 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Zhu chengshun<br>Quality Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Secondary Contact<br>Person: | Mike Gu<br>Regulatory Manager<br>Guangzhou Osmunda Medical Device Consulting Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-M32 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<br>90LLZ |
| Predicate Device(s): | RADIFORCE GS310;K060845 |
| Device Description: | JUSHA-M32 Medical Display is the display system with the<br>high resolution(2048 x 1536), high luminance(700 cd/m²),<br>and<br>256 simultaneous shades of gray out of a palette of<br>4096, 8 DICOM look up table inside, the product is consisted<br>of the following components:<br>- 21.3 inch, mono-TFT Liquid Crystal Display<br>- Motherboard HDVI-3M V1.0<br>- JUSHA-M32 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: |
| | |
| | 1. IEC 60601-1 Medical equipment medical electrical<br>equipment - Part 1: General requirements for<br>basic safety and essential performance 1988+A1:<br>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 -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests. |
| Intended Use: | JUSHA-M32 Medical Display is intended to be used in<br>displaying and viewing digital images for diagnosis of X-ray<br>or MRI, etc. by trained medical practitioners. The device is<br>not specified for digital mammography system. |
| Technology: | JUSHA-M32 Medical Display is the display system with the<br>high resolution monitor (3 megapixels) with electronic<br>capabilities for evaluation of high resolution medical images,<br>high luminance (700 cd/m²) and 256 simultaneous shades<br>of gray out of a palette of 4096, 8 DICOM look up table<br>inside |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The Medical Display complies with voluntary standards as<br>detailed in Section 9, 11 and 17 of this premarket<br>submission. The following quality assurance measures were<br>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, Medical Display,<br>did not require clinical studies to support substantial<br>equivalence. |
| | The proposed device is Substantially Equivalent (SE) to the<br>predicate device which is US legally market device.<br>Therefore, the subject device is determined as safe and<br>effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the<br>JUSHA-M32 Medical Display to be as safe, as effective, and<br>performance is substantially equivalent to the predicate<br>device(s). |

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## 510(k) Premarket Notification Submission

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# 510(k) Premarket Notification Submission

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

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

August 21, 2013

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD % MIKE GU GUANGZHOU OSMUNDA MEDICAL DEVICE CONSULTING CO. 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT GUANGZHOU, GUANGDONG CHINA CH 510420

Re: K131391

Trade/Device Name: JUSHA-M32 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 15, 2013 Received: August 9, 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 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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Page 2 - Mr. Mike Gu

forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/dcfault.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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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### Indications for Use

510(k) Number (if known): K131391

Device Name: JUSHA-M32 Medical Display

Indications for Use:

JUSHA-M32 Medical Display 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 is not specified for digital mammography system.

Prescription Use JJ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(m.h.p)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

> K131391 510(k)_