JUSHA-M52C Medical Display

K150746 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Apr 14, 2015 · Radiology

Device Facts

• Record ID: K150746
• Device Name: JUSHA-M52C Medical Display
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Apr 14, 2015
• 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 for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.

Device Story

JUSHA-M52C is a 21.3-inch monochrome TFT LCD medical display system; provides high-resolution (2048 x 2560) visualization for medical images. Device receives digital image data; processes via internal DICOM look-up table (LUT) to ensure accurate grayscale reproduction (256 shades from 4096 palette); outputs high-luminance (700 cd/m²) images for clinical review. Used by radiologists and trained medical practitioners in clinical environments for diagnostic analysis. Output enables clinicians to view high-resolution medical images, including mammography, to support diagnostic decision-making and patient care.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including module verification, system integration testing, and final acceptance testing against safety and performance standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

21.3-inch mono-TFT LCD; 2048 x 2560 resolution; 700 cd/m² luminance; 256 grayscale levels from 4096 palette; internal DICOM LUT. 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 review and analyze medical images, including digital mammography. No specific age or gender restrictions provided.

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-M52C (K131390)
• RadiForce G51

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 14, 2015

Nanjing Jusha Display Technology Co., LTD % Mr. Ma Jing Certification Engineer 301 Hanzhongmen Street, 8F Block A. No.1 Nanjing International Service Outsourcing MANSION, NANJING 210036 CHINA

Re: K150746

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: PGY Dated: March 16, 2015 Received: March 23, 2015

Dear Mr. 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 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.

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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 A Ochs

Robert Ochs, PhD. Acting 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) K150746

Device Name JUSHA-M52C Medical Display

Indications for Use (Describe)

JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.

| 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: | July 21,2013 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology<br>Co., Ltd<br>Add: 301, Hanzhongmen Street, 8F Block A, No.1, Nanjing<br>International Service Outsourcing Mansion, Nanjing, 210036<br>China |
| Contact Person: | Ma Jing<br>Certification engineer<br>301, Hanzhongmen Street, 8F Block A, No.1, Nanjing<br>International Service Outsourcing Mansion, Nanjing, 210036<br>China<br>Tel: [phone],<br>fax [phone] |
| 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): | JUSHA-M52C;K131390 |
| Device Description: | JUSHA-M52C Medical Display is the display system with the<br>high resolution(2048 x 2560), high luminance(700 cd/m² ),<br>and 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-M52C Medical Display software<br>- Power Adapter<br>- Data Cable. |
| | The Medical Display is designed, tested, and will be<br>manufactured in accordance with both mandatory and<br>voluntary standards:<br>1. IEC 60601-1Medical equipment medical electrical<br>equipment - Part 1: General requirements for<br>basic safety and essential performance<br>IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ |
| | EN 60601-1: 2006/AC: 2010 |
| | 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-M52C Medical Display is intended to be used for<br>review and analysis by trained medical practitioners in<br>displaying and viewing various kinds of medical images<br>including digital mammography system. |
| Technology: | JUSHA-M52C Medical Display is the display system with the<br>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<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: |
| | The Medical Display complies with voluntary standards as<br>following:<br>1 IEC 60601-1Medical equipment medical electrical<br>equipment - Part 1: General requirements for basic<br>safety and essential performance |
| | IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ |
| | EN 60601-1: 2006/AC: 2010 |
| | 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 |
| | The following quality assurance measures were applied to<br>the development of the system:<br>• Risk Analysis<br>• Requirements Reviews |

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| | •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, 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-M52C Medical Display to be as safe, as effective, and<br>performance is substantially equivalent to the predicate<br>device(s). |