JUSHA-M33C LCD MONITOR

K141690 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Aug 1, 2014 · Radiology

Device Facts

• Record ID: K141690
• Device Name: JUSHA-M33C LCD MONITOR
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-M33C 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 is not specified for digital mammography system.

Device Story

JUSHA-M33C is a 21.3-inch monochrome TFT LCD monitor for diagnostic radiology. Input signals (X-ray, MRI) received via DVI or DisplayPort; processed by internal electronics to display high-resolution (2048x1536) images. Features include ambient brightness adaptation and presence induction for automatic display adjustment. Includes Color/Grayscale Auto-identification (CGA) function to apply appropriate Look-Up Tables (DICOM for grayscale, GAMMA 2.2 for color). Used by radiologists/clinicians in clinical settings to view medical images for diagnostic decision-making. Benefits include optimized image visualization through automated luminance and grayscale calibration.

Clinical Evidence

No clinical data; substantial equivalence supported by bench testing and performance verification.

Technological Characteristics

21.3-inch Mono-TFT LCD panel; 2048x1536 resolution; 1000 cd/m² luminance; 1400:1 contrast ratio; LED backlight. Connectivity via DVI-D and DisplayPort. Includes ambient brightness sensor and presence induction system. Software includes DICOM and GAMMA look-up tables. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or MRI. Not indicated for digital mammography.

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

• EIZO GX340 (K113784)

Submission Summary (Full Text)

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

August 1, 2014

Nanjing Jusha Display Technology Co., Ltd. % Ms. Li Le Certification Manager 8A, Block 1, Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street, Nanjing 210036 CHINA

Re: K141690

Trade/Device Name: Jusha-M33C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 24, 2014 Received: June 30, 2014

Dear Ms. Le:

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,

Smh.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: January 31, 2017 See PRA Statement below.

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

#### K141690

Device Name

#### JUSHA-M33C LCD Monitor

Indications for Use (Describe)

JUSHA-M33C 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 is not specified for digital mammography system.

Type of Use (Select one or both, as applicable)

2 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)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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<br>Add: 8A, Block 1. Nanjing International Service Outsourcing<br>Mansion, No. 301, Hanzhongmen street, Nanjing, China. |
| Contact Person: | Li le<br>Certification Manager<br>Nanjing Jusha Display Technology Co., Ltd<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | JUSHA-M33C LCD Monitor |
| Common/Usual Name: | 3MP Monochrome LCD Monitor |
| Classification Name: Product<br>Code: | Display, Diagnostic Radiology 21CFR 892.2050<br>PGY |
| Predicate Device(s): | EIZO GX340;K113784 |
| Device Description: | JUSHA-M33C LCD Monitor is the display system with the high<br>resolution (2048*1536), high luminance (1000 cd/m²), and 1024<br>simultaneous shades of gray out of a palette of 4096, 10 DICOM look<br>up table and 3 GAMMA look up table inside. JUSHA-M33C has<br>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.<br>The product is consisted of the following components:<br>- 21.3inches, Mono-TFT LCD Panel<br>- JUSHA- 45T motherboard/FR-4/REV:0.9<br>- JUSHA-M33C LCD Monitor software<br>- Power Adapter<br>- Data Cable.<br>The LCD Monitor is designed, tested, and will be manufactured in<br>accordance with both mandatory and voluntary standards:<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. |

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| Intended Use: | JUSHA-M33C 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 is not specified for digital<br>mammography system. | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Technology: | JUSHA-M33C LCD Monitor is the display system with the high<br>resolution monitor (3 megapixels) with electronic capabilities for<br>evaluation of high resolution medical images, high luminance (1000<br>cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,<br>10 DICOM look up table and 3 GAMMA look up table inside. In<br>particular, JUSHA-M33C 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-M33C 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>The LCD Monitor complies with voluntary standards as following:<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>JUSHA-M33C is substantially equivalent to EIZO GX340. JUSHA-<br>M33C employs the maximum resolution values same as that of EIZO<br>GX340. Comparison table of the principal characteristics of 2 devices<br>is shown in the Attachment 1.<br>The following quality assurance measures were applied to the<br>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: | | |
| | | | |
| | The subject of this premarket submission, LCD Monitor, did not<br>require clinical studies to support substantial equivalence. | | |
| | The proposed device is Substantially Equivalent (SE) to the predicate<br>device which is US legally market device. Therefore, the subject<br>device is determined as safe and effectiveness. | | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA-<br>M33C LCD Monitor to be as safe, as effective, and performance is<br>substantially equivalent to the predicate device(s). | | |

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### 510(k) Premarket Notification Submission

## Attachment 1

| Attributes | Predicate Device | Proposed Device |
|---------------------------|--------------------------------------------|----------------------------------------|
| Product | EIZO GX340 | JUSHA-M33C LCD Monitor |
| 510(k) Number | K113784 | K141690 |
| Screen technology | 21.3" Monochrome TFT LCD<br>Panel | 21.3inches, Mono-TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 176°,Vertical 176° | Horizontal 176°,Vertical 176° |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 |
| Display area | 324.8 (H) x 433.1 (V) mm | 325.00 (H) x 433.00 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31~127 kHz;29~61.5 Hz | 96.7kHz;60Hz |
| Recommended<br>Luminance | 500cd/m² | 500cd/m² |
| Pixel Pitch | 0.2115x0.2115 mm | 0.2115x0.2115 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port) : 1024<br>8-bit: 256 | 4096 |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided |
| Input signals | DVI standard 1.0,<br>DisplayPort 1.1a | DVI standard 1.0,<br>DisplayPort 1.1a |
| Input terminational | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 |

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| | 510(k) Premarket Notification Submission | | | | |
|--|------------------------------------------|--|--|--|--|
| | | | | | |

| Display controller | Off the shelf | Off the shelf |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Requirement | AC 100~240V 50~60Hz | AC 100~240V 50~60Hz |
| Power<br>Consumption/Save<br>Mode | 36W/less than1.6W | 45W/less than 3W |
| Power Management | DVI DMPM<br>DisplayPort 1.1a | DVI DMPM<br>DisplayPort 1.1a |
| USB Ports/standard | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 |
| Dimensions w/o stand<br>(W x H x D) | Without stand:<br>376mmx505mmx98mm<br>With stand:<br>376mmx599mmx245.5 mm | Without stand:<br>382mm x490mm x75mm With stand:<br>382mm x533mm x238mm |
| Applicable standard | 1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)<br>2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | 1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)<br>2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. |