C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor

K212231 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Mar 25, 2022 · Radiology

Device Facts

• Record ID: K212231
• Device Name: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
• Applicant: Nanjing Jusha Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Mar 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in 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 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

Display system for medical imaging; inputs digital image data from medical workstations; transforms data via 16-bit grayscale LUT and high-resolution color-TFT LCD panel; outputs visual images for clinical review. Used in clinical settings by radiologists/physicians. Features ambient brightness adaptation, real-time DICOM automatic calibration, full-screen brightness equalization, and presence induction. Output allows clinicians to perform diagnostic review of mammography and tomosynthesis images; aids in clinical decision-making by providing high-fidelity, calibrated visualization of diagnostic data.

Clinical Evidence

Bench testing only. No clinical or animal studies were required. Bench testing included measurement of angular luminance response, luminance/chromaticity non-uniformity (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

31-inch Color-TFT LCD panel; 4200x2800 resolution; 800 cd/m² luminance; 16-bit grayscale (65536 levels); built-in DICOM LUT. Features: ambient brightness adaptation, real-time DICOM auto-calibration, full-screen brightness equalization, presence induction. Connectivity: DisplayPort 1.2a, HDMI 2.0. Power: 100-240V AC. Standards: IEC 60601-1, IEC 60601-1-2, FCC Part 15.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including standard and multi-frame digital mammography and breast tomosynthesis, for review, analysis, and diagnosis.

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 JUSHA-M550G (K190848)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features 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. % Donny Lee Certification Engineer 8A, Block 1. No. 301, Hanzhongmen Street Nanjing, Jiangsu 210036 CHINA

March 25, 2022

#### Re: K212231

Trade/Device Name: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: January 24, 2022 Received: January 24, 2022

### 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

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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/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 medical devices and radiation-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, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch Division of Radiological Health OHT7: Office of in vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212231

Device Name C1210G/JUSHA-C1210G/C1210/JUSHA-C1210 LCD Monitor

Indications for Use (Describe)

JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in 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 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)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CER 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CER 801 Subpart C) |

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# K212231

# 510(k) Summary

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

| Date: | May 26, 2021 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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><br>Dongdong Li<br><br>Certification Manager<br><br>Nanjing Jusha Display Technology Co., Ltd<br><br>Tel: [phone]<br><br>Fax: [phone] |
| Device Trade Name: | JUSHA-C1210G LCD Monitor, JUSHA-C1210 LCD Monitor,<br>C1210G LCD Monitor, C1210 LCD Monitor |
| Common/Usual Name: | 12MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050<br>PGY |
| Product Code: | |
| Predicate Device(s): | JUSHA JUSHA-M550G; K190848 |
| Device Description: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the<br>display system with the high resolution (4200×2800), high<br>luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in<br>DICOM standard LUT. In particular, JUSHA- C1210G has ambient<br>brightness adapt inside. In particular, JUSHA- C1210G has ambient<br>brightness adapting, real-time DICOM automatic calibration, full-<br>screen brightness equalization 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><br>The product is consisted of the following components:<br><br>- 31" Color-TFT LCD Panel<br><br>- DMF2604AR0/main board/REV1.0<br><br>- JUSHA-C1210G LCD Monitor software<br><br>- Power Adapter |

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| | - 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. | | |
| | 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-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is<br>intended to be used in displaying and viewing digital images,<br>including standard and multi-frame digital mammography, for review,<br>analysis, and diagnosis by trained medical practitioners. It is specially<br>designed for 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 designed<br>for breast tomosynthesis applications. | | |
| Technology: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the<br>display system with the high resolution ( $4200\times2800$ ), high<br>luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in<br>DICOM standard LUT. In particular, JUSHA- C1210G has ambient<br>brightness adapt inside. In particular, JUSHA- C1210G has ambient<br>brightness adapting, real-time DICOM automatic calibration, full-<br>screen brightness equalization and presence induction system, with<br>these this display can automatic adjustment according to different<br>requirements in order to achieve the best results. | | |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The LCD Monitor complies with voluntary standards as following: | | |
| | 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. | | |

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| 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 -<br>Requirements and tests |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | JUSHA-C1210G is substantially equivalent to JUSHA JUSHA-<br>M550G. JUSHA-C1210G employs the maximum resolution values<br>larger than that of JUSHA-M550G. Comparison table of the principal<br>characteristics of 2 devices is shown in the Product Comparison. |
| | |
| | The following quality assurance measures were applied to the<br>development of the system: |
| | • Risk Analysis<br>• Requirements Reviews<br>• 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: | |
| | 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>C1210G LCD Monitor to be as safe, as effective, and performance is |

# 12.1 Product Comparison

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This comparison identifies the similarities and differences of the proposed JUSHA-C1210G LCD Monitor device to the legally marketed predicate JUSHA JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.

| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD<br>Monitor | |
| 510(k) Number | K190848 | / | |
| Display Performance/Specifications | | | |
| Screen<br>technology | 21.3inches, Mono-TFT LCD<br>Panel | 31inches, Color-TFT LCD<br>Panel | C1210G is larger<br>than M550G |
| Viewing angle<br>(H, V) | Horizontal 170°,Vertical<br>170° | Horizontal 178°,Vertical<br>178° | C1210G is better<br>than M550G |
| Resolution | $2560 \times 2048/2048 \times 2560$ | $4200\times2800$ | C1210G is larger<br>than M550G |
| Display area | $422.4(H)\times377.92(V)$ mm | $676.9(H)\times459.7(V)$ mm | C1210G is larger<br>than M550G |
| Contrast Ratio | 1700:1 | 1500:1 | C1210G is<br>smaller than<br>M550G, but the<br>difference does<br>not make<br>difference to the<br>diagnosis. |
| Supplied<br>CURVE | DICOM\CIE\GAMMA2.2\G<br>AMMA2.4 | DICOM\CIE\GAMMA2.2\G<br>AMMA2.4 | Same |
| DICOM<br>calibrated<br>luminance | 1000cd/m² | 800cd/m² | C1210G is<br>smaller than<br>M550G, and<br>both of them<br>meet the<br>requirements of<br>AAPM<br>regarding breast<br>diagnosis. |
| Pixel Pitch | $0.165\times0.165$ mm | $0.1554\times0.1554$ mm | C1210G is better<br>than M550G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD<br>Monitor | |
| 510(k) Number | K190848 | / | |
| 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 | DisplayPort 1.2a | The difference<br>only shows that<br>they have<br>different<br>input,has nothing<br>to do with the<br>display function. |
| Input<br>terminational | DVI-D×1,<br>DisplayPort×1 | DisplayPort×2 | The difference<br>only shows that<br>they have<br>different<br>input,has nothing<br>to do with the<br>display function. |
| Output signals | DisplayPort 1.2a | HDMI 2.0 | The difference<br>only shows that<br>they have<br>different output,<br>has nothing to do<br>with the display<br>function. |
| Output<br>Terminational | DisplayPort×1 | HDMI×1 | The difference<br>only shows that<br>they have<br>different output,<br>has nothing to do<br>with the display<br>function. |
| Display<br>controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power<br>Requirement | AC 100~240V 50~60Hz | AC 100~240V 50~60Hz | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD<br>Monitor | |
| 510(k) Number | K190848 | / | |
| Power<br>Consumption/Save Mode | 55W/less than 0.5W | 150W/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>DisplayPort 1.2a | DisplayPort 1.2a | The difference<br>only shows that<br>they have<br>different power<br>Management,<br>has nothing to do<br>with the display<br>function. |
| Miscellaneous Features/Specifications | | | |
| USB<br>Ports/standard | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 3.0 | C1210G is better<br>than M550G. |
| Dimensions w/o<br>stand<br>(W×H×D) | Without stand:<br>$363mm×475mm×66mm$<br>With stand:<br>$363mm×635mm×238mm$ | Without stand:<br>$701.3 mm× 500 mm×$<br>86.8mm<br>With stand:<br>$701.3 mm× 589 mm×$<br>245mm | Different<br>housing design<br>due to the<br>different panel<br>size. |
| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD<br>Monitor | |
| 510(k) Number | K190848 | / | |
| Indication for<br>use | JUSHA-M550G/JUSHA-<br>M550/M550G/M550 LCD<br>Monitor is intended to be<br>used in displaying and<br>viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially de displaying<br>and viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially designed for<br>breast tomosynthesis<br>applications. | JUSHA-C1210G/JUSHA-<br>C1210/ C1210G/ C1210<br>LCD Monitor is intended to<br>be used in displaying and<br>viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially de displaying<br>and viewing digital images,<br>including standard and<br>multi-frame digital<br>mammography, for review,<br>analysis, and diagnosis by<br>trained medical practitioners.<br>It is specially designed for<br>breast tomosynthesis<br>applications. | Same |

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| Attributes | Predicate Device | Proposed Device | Discussion of<br>Differences |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…