C350/C350G LCD Monitor; M550/M550G LCD Monitor

K231170 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Jun 7, 2023 · Radiology

Device Facts

• Record ID: K231170
• Device Name: C350/C350G LCD Monitor; M550/M550G LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Jun 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

C350G/C350/JUSHA-C350G/JUSHA-C350 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. M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Story

LCD monitors (C350G/M550G) for medical image display; input via DVI/DisplayPort from external graphic controllers; output is high-resolution visual display for diagnostic review. Features include ambient brightness adaptation, real-time DICOM automatic calibration, and presence induction. Used in clinical settings by trained medical practitioners. Output assists in diagnosis of X-ray, MRI, and mammography (M550G only). Benefits include optimized image quality and consistency via automated calibration and brightness equalization.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including luminance response, non-uniformity, contrast ratio, temporal response, and luminance stability, alongside electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2) compliance.

Technological Characteristics

21.3" Color (C350G) or Mono (M550G) TFT LCD panels; LED backlight; 16-bit DICOM LUT; DVI/DisplayPort connectivity; ambient light sensor; built-in calibration sensor; DC 24V power; standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis. C350 series for X-ray/MRI (excluding mammography). M550 series for standard/multi-frame digital mammography and breast tomosynthesis.

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

• C270G (K183498)
• BARCO MDMG-5221 (K161229)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301, Hanzhongmen street Naniing, Jiangsu 210036 CHINA

June 7, 2023

#### Re: K231170

Trade/Device Name: C350/C350G LCD Monitor: M550/M550G LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 25, 2023 Received: April 25, 2023

Dear Donny Lee:

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, PhD. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K231170

Device Name C350/C350G LCD Monitor M550/M550G LCD Monitor

#### Indications for Use (Describe)

C350G/C350/JUSHA-C350G/JUSHA-C350 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.

M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

## (K231170)

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

| Date: | Apr 16, 2023 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| | Add: 8A, Block 1. Nanjing International Service Outsourcing<br>Mansion, No. 301, Hanzhongmen street, Nanjing City, Jiangsu<br>Province, 210036 China. |
| Contact Person: | Donny Lee |
| | Certification Engineer |
| | Nanjing Jusha Display Technology Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Device Trade Name: | C350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCD<br>Monitor, JUSHA-C350 LCD Monitor (There is no difference between<br>C350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCD<br>Monitor and JUSHA-C350 LCD Monitor except for labeling as they<br>are marketed in different areas. It does not affect their safety or<br>effectiveness in any terms. )<br>M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550G LCD<br>Monitor, JUSHA-M550 LCD Monitor (There is no difference<br>between M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550G<br>LCD Monitor and JUSHA-M550 LCD Monitor except for labeling as<br>they are marketed in different areas. It does not affect their safety or<br>effectiveness in any terms. ) |
| Common/Usual Name: | 3MP LCD Monitor and 5MP LCD Monitor |
| Classification Name: | Medical Image Management and Processing System, 21 CFR<br>892.2050 |
| Product Code: | PGY |
| Device Class: | Class II |

{4}------------------------------------------------

| Predicate Device(s): | C270G;K183498<br>BARCO MDMG-5221; K161229 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Medical Image Management and Processing System, 21 CFR<br>892.2050 |
| Product Code: | PGY |
| Device Class: | Class II |
| Device Description: | C350G LCD Monitor is the display system with the high resolution<br>(2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors,<br>built-in DICOM standard LUT. In particular, C350G has ambient<br>brightness adapting, real-time DICOM automatic calibration and<br>presence induction system, with these this display can automatic<br>adjustment according to different requirements in order to achieve the<br>best results.<br><br>The product is consisted of the following components:<br>- 21.3" Color TFT LCD Panel<br>- DMX3304AR2/main board<br>- C350G LCD Monitor software<br>- a graphic card<br>- a graphic card driver CD<br>- a CGA software CD<br>- an AC power cord<br>- an external power supply<br>- a DVI cable<br>- a DP cable<br>- a USB cable<br><br>M550G LCD Monitor is the display system with the high resolution<br>(2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale<br>(65536 level), built-in DICOM standard LUT. In particular, M550G |

{5}------------------------------------------------

has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, fullscreen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Mono-TFT LCD Panel - DMX3304AR2/main board - M550G LCD Monitor software - a graphic card - a graphic card driver CD - an AC power cord - an external power supply - a DVI cable - a DP cable - a USB cable In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the C350G and M550G LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. The software doesn't include any functions of image manipulation. The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - - Part 1: General requirements for basic safety and essential performance.

{6}------------------------------------------------

| 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,<br>Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic disturbances -<br>Requirements and tests. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended<br>to be used in displaying and viewing digital images for diagnosis of X-<br>ray or MRI, etc. by trained medical practitioners. The device is not<br>specified for digital mammography system.<br><br>M550G/M550/JUSHA-M550G/JUSHA-M550 LCD Monitor is<br>intended to be used in displaying and viewing digital images, including<br>standard and multi-frame digital mammography, for review, analysis,<br>and diagnosis by trained medical practitioners. It is specially de<br>displaying and viewing digital images, including standard and multi-<br>frame digital mammography, for review, analysis, and diagnosis by<br>trained medical practitioners. It is specially designed for breast<br>tomosynthesis applications. |
| Technology: | C350G LCD Monitor is the display system with the high resolution<br>(2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors,<br>built-in DICOM standard LUT. In particular, C350G LCD Monitor has<br>ambient brightness adapting, real-time DICOM automatic calibration<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.<br><br>M550G LCD Monitor is the display system with the high resolution<br>(2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale<br>(65536 level), built-in DICOM standard LUT. In particular,<br>M550G/M550 LCD Monitor has ambient brightness adapt inside. In<br>particular, M550G LCD Monitor has ambient brightness adapting, real-<br>time DICOM automatic calibration, full-screen brightness equalization<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><br>The LCD Monitor complies with voluntary standards as following:<br><br>1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-<br>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, Medical<br>electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests<br><br>C350G LCD Monitor is substantially equivalent to C270G. M550G<br>LCD Monitor is substantially equivalent to BARCO MDMG-5221.<br>They have equivalent characteristics and functions according to<br>comparison table, please refer to 2. Product Comparison<br><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)<br>Summary of Clinical Tests:<br><br>The subject of this premarket submission, LCD Monitor, did not<br>require clinical studies to support substantial equivalence.<br><br>The proposed devices are Substantially Equivalent (SE) to the<br>predicate devices which is US legally market device. Therefore, the<br>subject devices are determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the C350G<br>LCD Monitor and M550G LCD Monitor to be as safe, as effective,<br>and performance are substantially equivalent to the predicate<br>device(s). |

{7}------------------------------------------------

### 2. Product Comparison

### 2. 1 C350G and its predicate device comparison

This comparison identifies the similarities and differences of the proposed C350G LCD monitor device to the legally marketed predicate C270G LCD Monitor device to which substantial equivalency is claimed.

{8}------------------------------------------------

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| | | 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 178°, Vertical<br>178° | Horizontal 178°, Vertical<br>178° | Same |
| Resolution | 1600 x 1200/1200 x 1600 | 2048x 1536 | C350G has a<br>higher resolution<br>than C270G<br>Image quality is<br>better than the<br>image displayed<br>on the predicate<br>device. |
| Display area | 432.0 (H) x 324.0(V) mm | 433.15(H) x324.86(V) mm | - |
| Contrast Ratio | 1400:1 | 1500:1 | C350G has a<br>higher contrast<br>ratio than C270G<br>Image quality is<br>better than the<br>image displayed<br>on the predicate<br>device. |
| DICOM<br>calibrated<br>luminance | 350cd/m² | Max:800cd/m²<br>Recommend:500cd/m² | C350G has a<br>higher calibrated<br>luminance than<br>C270G<br>Image quality is<br>better than the<br>image displayed<br>on the predicate<br>device. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Pixel Pitch | 0.27x0.27 mm | 0.2115x0.2115 mm | C350G has a<br>smaller pixel<br>pitch than<br>C270G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | same |
| Scanning<br>frequency (H; V) | 37.9~75kHz;60Hz | 74.2~97.68kHz;60Hz | - |
| Luminance<br>calibration | Built in calibration sensor<br>provided | Built in calibration sensor<br>provided | Same |
| Video Signal Input | | | |
| Input signals | DVI standard 1.0,<br>DisplayPort 1.2a | DVI standard 1.0,<br>DisplayPort 1.2a | Same |
| Input<br>terminational | DVI-D x 1,<br>DisplayPort x 1 | DVI-D x 1,<br>DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| Terminational<br>Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | DC 24V | DC 24V | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Power<br>Consumption/Sa<br>ve Mode | 50W/less than 0.5W | 90W/less than 0.5W | The differences<br>caused by<br>components used<br>in the LCD<br>Monitor. This<br>only shows the<br>power<br>consumption is<br>different,<br>nothing to do<br>with the display<br>function |
| Power<br>Management | DVI DMPM<br>Display Port 1.1a | DVI DMPM<br>Display Port 1.2a | Same |
| Miscellaneous Features/Specifications | | | |
| USB<br>Ports/standard | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | Same |
| Dimensions w/o<br>stand<br>(W x H x D) | Without stand:<br>382mm x490mm x77mm<br>With stand:<br>382mm x635mm x238mm | Without stand:<br>382mm x490mm x77mm<br>With stand:<br>363mm x(530-635)mm<br>x238mm…