JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

K183499 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Feb 4, 2019 · Radiology

Device Facts

• Record ID: K183499
• Device Name: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Feb 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M350G/JUSHA-M350/M350G/M350 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

High-resolution (2048x1536) 21.3-inch monochrome LCD monitor for diagnostic radiology; inputs digital image data via DVI-D or DisplayPort; transforms inputs using built-in DICOM standard LUT; produces grayscale images (16-bit, 65536 levels). Features include ambient brightness adaptation, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction, and focusview function. Used in clinical settings by radiologists/physicians to view medical images; output assists in clinical diagnosis. Benefits include optimized image quality and automated display adjustments for diagnostic accuracy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including measurement of angular luminance dependency, luminance/chromaticity non-uniformity (per TG18 guidelines), small-spot contrast ratio, temporal response, and luminance stability. Electrical safety and EMC testing confirmed compliance with IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

21.3" Color TFT LCD panel; 2048x1536 resolution; 1000 cd/m² luminance; 16-bit grayscale; LED backlight. Connectivity: DVI-D, DisplayPort. Features: ambient brightness sensor, presence induction. Standards: IEC 60601-1:2012, IEC 60601-1-2:2014, FCC Part 15 Subpart B. Software includes DICOM LUT and calibration algorithms.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or 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

• JUSHA-M33C (K141690)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A. 8/F. Bldg 1. No. 301. Hanzhongmen Street Nanjing, Jiangsu 210036 CHINA

February 4, 2019

### Re: K183499

Trade/Device Name: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: Class II Product Code: PGY Dated: December 20, 2018 Received: December 20, 2018

#### Dear Zilong Liang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K183499

Device Name

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

Indications for Use (Describe)

JUSHA-M350G/JUSHA-M350/M350 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.

| 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 K183499

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

| Date: | December 6, 2018 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Add: 301, 8F Block A, No.1, Nanjing International Service<br>Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China<br>Zilong Liang<br>Certification Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor |
| Common/Usual Name: | 3MP Monochrome LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | JUSHA-M33C; K141690 |
| Device Description: | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1536), high luminance (1000 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M350G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results.<br>The product is consisted of the following components:<br>- 21.3" Mono-TFT LCD Panel<br>- DMX0704AR0/main board/REV1.1<br>- JUSHA-M350G 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: |
| | 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+C1:2009+A2:2010,<br>CAN/CSA C22.2 NO.60601-1:14, Medical equipment<br>medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance.<br>2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,<br>CFR 47 FCC Part15 subpart B: 2017, Medical electrical<br>equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is |
| | intended to be used in displaying and viewing digital images for<br>diagnosis of X-ray or MRI, etc. by trained medical practitioners. The<br>device does not support the display of mammography images for<br>diagnosis. |
| Technology: | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the |
| | display system with the high resolution (2048*1536), high luminance |
| | (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM |
| | standard LUT. In particular, JUSHA-M350G has ambient brightness |
| | adapting, real-time DICOM automatic calibration, full-screen |
| | brightness equalization, presence induction and focusview function, |
| | with these this display can automatic adjustment according to |
| | different requirements in order to achieve the best results. |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests: |
| | The LCD Monitor complies with voluntary standards as following: |
| | 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI<br>ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2<br>NO.60601-1:14, Medical equipment medical electrical equipment<br>- Part 1: General requirements for basic safety and essential<br>performance. |
| | 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47<br>FCC Part15 subpart B: 2017, Medical electrical equipment - Part<br>1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic disturbances - |
| | Requirements and tests. |
| | |
| | JUSHA-M350G/JUSHA-M350/M350G/M350 is substantially |
| | equivalent to JUSHA-M33C. |
| | JUSHA-M350G/JUSHA-M350/M350G/M350 employs the maximum |
| | resolution values same as that of JUSHA-M33C. Comparison table of |
| | the principal 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-M350G 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-M350G LCD Monitor device to the legally marketed predicate JUSHA-M33C LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-M33C | JUSHA-M350G/JUSHA-M3<br>50/M350G/M350 | |
| 510(k) Number | K141684 | / | |
| 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 178°;Vertical<br>178 ° | - |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 | Same |
| Display area | 324.864(H) x 433.152 (V)<br>mm | 323.942(H) x 431.923 (V)<br>mm | - |
| Contrast Ratio | 1400:1 | 1400:1 | same |
| Scanning<br>frequency (H; V) | 96.7kHz;60Hz | 37.9~95.4kHz;60Hz | 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 | 450cd/m² | - |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2109x0.2109 mm | - |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-M33C | JUSHA-M350G/JUSHA-M3<br>50/M350G/M350 | |
| 510(k) Number | K141684 | / | |
| Display Colors | 12-bit ,68.7 billion colors | 16-bit , 281.47 Trillion<br>colors | The<br>JUSHA-M350G<br>LCD Monitor<br>uses a color bit<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. |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| | | Video Signal Input | |
| Input signals | DVI-D (dual link) x 1,<br>DisplayPort x 1 | DVI-D (dual link) x 1,<br>DisplayPort x 1 | - |
| Output Signal | - | DisplayPort x 1 | - |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | AC 100~240V 50~60Hz | DC 24V | - |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA-M33C | JUSHA-M350G/JUSHA-M3<br>50/M350G/M350…