Hisense LCD monitor HMD2G21S, HMD3G21S

K222132 · Qingdao Hisense Medical Equipment Co., Ltd. · PGY · Nov 8, 2022 · Radiology

Device Facts

• Record ID: K222132
• Device Name: Hisense LCD monitor HMD2G21S, HMD3G21S
• Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Nov 8, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

1) The 2MP Monochrome LCD Monitor HMD2G21S 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. 2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Device Story

Hisense HMD2G21S (2MP) and HMD3G21S (3MP) are monochrome LCD monitors for medical imaging. Devices receive digital image inputs (DSA, MRI, DR, CR, CT, PET) via DVI-D or DisplayPort interfaces. Monitors transform inputs into grayscale visual output compliant with DICOM Part 14 standard. Used in clinical settings by trained medical practitioners for diagnostic review. Devices feature built-in ambient light sensors and front-facing sensors for luminance calibration. Output allows clinicians to view and interpret medical images to support diagnostic decision-making. Benefits include high-resolution, calibrated display performance for accurate radiological assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing in accordance with AAPM Task Group 18 (TG18) guidelines for display performance, including spatial resolution, pixel defects, artifacts, temporal response, luminance, and DICOM GSDF conformance. Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Gray scale TFT LED-backlit LCD panels. 21.3-inch form factor. 14-bit LUT. Connectivity: DVI-D, DisplayPort, USB 2.0. Integrated ambient light and front-facing calibration sensors. Compliance: IEC 60601-1, IEC 60601-1-2. DICOM Part 14 compliant.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray, MRI, DSA, CR, CT, and PET. Not indicated for mammography 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-M260G LCD Monitor (K183497)
• JUSHA-M33C LCD Monitor (K141690)

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 & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

Qingdao Hisense Medical Equipment Co., Ltd. % Lu Zhonghao Quality Engineer No. 399 Songling Road, Laoshan District Oingdao, Shandong 266100 CHINA

#### Re: K222132

November 8, 2022

Trade/Device Name: Hisense LCD monitor (HMD2G21S, HMD3G21S) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: October 7, 2022 Received: October 14, 2022

Dear Lu Zhonghao:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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, Ph.D. 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

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### Indications for Use

510(k) Number (if known) K222132

Device Name

LCD Monitor( HMD2G21S,HMD3G21S)

Indications for Use (Describe)

1) The 2MP Monochrome LCD Monitor HMD2G21S 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.

2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

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) Premarket Notification Submission

# Section5: 510(k) Summary

# LCD monitor

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## Section5: 510(k) Summary

# (K222132)

## 1. Applicant information

| Date | Oct. 7, 2022 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Qingdao Hisense Medical Equipment Co.,Ltd.<br>Address: No. 399 Songling Road, Laoshan District<br>266100, Qingdao, Shandong, P. R. China |
| Contact Person: | <b>Primary Contact Person</b><br>Lu zhonghao<br>Quality Engineer<br>Qingdao Hisense Medical Equipment Co.,Ltd.<br>Mail:[e-mail]<br>Tel: [phone]<br>Fax:[phone]<br><br><b>Secondary Contact Person</b><br>Wu yalan<br>RA Manager<br>Qingdao Hisense Medical Equipment Co.,Ltd.<br>Mail: Wu [e-mail]<br>Tel: [phone]<br>Fax:[phone] |

## 2.Device information

| Device Trade Name: | Hisense LCD monitor HMD2G21S,HMD3G21S |
|----------------------|----------------------------------------------|
| Common/Usual Name: | 2M/3M Monochrome LCD Monitor |
| Classification | II |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |

## 3. Predicate Device(s):

| Trade Name | JUSHA-M260G LCD Monitor |
|---------------|-------------------------------------------|
| 510(k) Number | K183497 |
| Product Code | PGY |
| Manufacturer | Nanjing Jusha Display Technology Co., Ltd |

| Trade Name | JUSHA-M33C LCD Monitor |
|---------------|-------------------------------------------|
| 510(k) Number | K141690 |
| Product Code | PGY |
| Manufacturer | Nanjing Jusha Display Technology Co., Ltd |

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### 4. Device Description

Hisense HMD2G21S, HMD3G21S LCD monitor complies with the DICOM Part 14 standard and is applicable to DSA, MRI, DR, CR, CT, and PET medical imaging. It is intended for trained medical practitioners and provides the image viewing and medical diagnostic functions.

## 5. Intended Use/Indication for Use

1) The 2MP Monochrome LCD Monitor HMD2G21S 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.

2) The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners.

The device does not support the display of mammography images for diagnosis.

# 6. Substantial Equivalence Comparison

### 6.1 HMD2G21S and its predicate

| Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k)<br>Number | K222132 | K183497 | - |
| Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| Device<br>type/model | HMD2G21S | JUSHA-M260G LCD Monitor | - |
| Intended<br>use/<br>Indication for<br>use | The 2MP Monochrome LCD<br>Monitor HMD2G21S is intended<br>to be used in displaying and<br>viewing digital images for<br>diagnosis of X-ray or MRI, etc.<br>by trained medical practitioners.<br>The device does not support the<br>display of mammography<br>images for diagnosis. | JUSHA-M260G LCD Monitor is<br>intended to be used in<br>displaying and viewing digital<br>images for diagnosis of X-ray or<br>MRI, etc. by trained medical<br>practitioners.<br>The device does not support the<br>display of mammography<br>images for diagnosis. | same |
| Prescription<br>or OTC | RX | RX | same |

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# 510(k) Premarket Notification Submission

| Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
|---------------------------|-----------------------------------------------------------|-----------------------------------------------------------|---------|
| Electrical<br>Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | same |
| Performance<br>testing | FDA guidance "Display devices<br>for Dignostic Radiology" | FDA guidance "Display devices<br>for Dignostic Radiology" | same |

# Table 02: Detailed Comparison Table

| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
|-------------------------------|----------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| ID | 510(k) Number | K222132 | K183497 | - |
| ID | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| ID | Device<br>type/model | HMD2G21S | JUSHA-M260G LCD<br>Monitor | - |
| | 1.Display Performance/Specifications | | | |
| 1.1 | Screen size | 21,3 inches (540 mm) | 21.3" | same |
| 1.2 | Screen<br>Technology | Gray scale TFT LCD panel | Mono-TFT LCD Panel | same |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical:<br>178° (CR ≥ 10) | Horizontal 178°,Vertical<br>178° | same |
| 1.4 | Pixel array | 1600 pixels (H) x 1200<br>pixels (V) | 1600 x 1200/1200 x 1600 | same |
| 1.5 | Display Area | 432 (H) x 324 (V) (mm) | 432.0 (H) x 324.0(V) mm | same |
| 1.6 | Pixel Pitch | 0,270 (H) x 0,270 (V) (mm) | 0.27x0.27 mm | same |
| 1.7 | Subpixel<br>driving | Not Applicable | Not Applicable | - |
| 1.8 | Contrast Ratio | 1800:1 (typ.) | 1400:1 | the specification<br>of the proposed<br>device is<br>superior to that<br>of the predicate<br>device |
| 1.9 | Frame rate /<br>refresh rate | 37.9~75kHz;60Hz | 37.9~75kHz;60Hz | same |
| 1.10 | Maximum<br>Brightness(typ | 1900 cd/m² | 1000cd/m² | the specification<br>of the proposed |
| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K183497 | - |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device<br>type/model | HMD2G21S | JUSHA-M260G LCD<br>Monitor | - |
| | | | | device is<br>superior to that<br>of the predicate<br>device |
| 1.11 | Recommende<br>d brightness<br>for | 400 cd/m² | 400cd/m² | same |
| 1.12 | Backlight type | LED | LED | same |
| 1.13 | Ambient<br>light<br>sensing | Built-in ambient light<br>sensor | Built in calibration sensor<br>provided | same |
| 1.14 | Response<br>Time | 19 ms | 16 ms | The difference<br>does not<br>affect diagnosis. |
| 1.15 | Aspect Ratio | 4:3 | 4:3 | same |
| 1.16 | Luminance<br>calibration | Front-facing sensor<br>Upper Computer Software | Built in calibration sensor<br>provided | Same, only<br>difference in<br>words. |
| 1.17 | Touch-screen | Not Applicable | Not Applicable | - |
| 2.Video Signals | | | | |
| 2.1 | Input Video<br>Signal | DVI-D x 1<br>DisplayPort x 1 | DVI-D x 1,<br>DisplayPort x 1 | same |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 | same |
| 2.3 | Video<br>bandwidth | DVI: 215MHz<br>DisplayPort : 215MHz | DVI: 215MHz<br>DisplayPort : 215MHz | same |
| 3.Power Related Specification | | | | |
| 3.1 | Power<br>Requirements | 24 V DC, 2,1 A | DC 12V | this difference<br>doesn't affect<br>product's<br>safety. |
| 3.2 | Power<br>Consumption/<br>save mode | 50.4W/Below 0.5 W | 50W/less than 0.5W | this difference<br>doesn't affect<br>product's<br>safety. |
| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K183497 | - |
| ID | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device<br>type/model | HMD2G21S | JUSHA-M260G LCD<br>Monitor | - |
| 3.3 | Power<br>Management | DVI DMPM<br>DisplayPort 1.2a | DVI DMPM<br>DisplayPort 1.1a | this difference<br>doesn't affect<br>product's<br>safety. |
| | | 4.Miscellaneous Features/Specifications | | |
| 4.1 | USB ports | 1 uplink port and 2<br>downlink ports/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | same |
| 4.2 | Grayscale<br>Tones(LUT) | 14-bit:16384 | 14-bit:16384 | same |
| 4.3 | User controls | Off the shelf | Off the shelf | same |
| 4.4 | Software/Firm<br>ware: | Built-in embedded<br>software | Built-in embedded<br>software | same |
| 4.5 | Dimensions<br>w/o stand<br>(W x H x D) | Without base:366 mm x<br>482 mm x 63 mm<br>With base:366 mm x<br>502-616 mm x 244 mm | Without stand: 382mm<br>x490mm x77mm<br>With stand: 382mm<br>x635mm x238mm | Different design<br>scheme, the<br>difference does<br>not affect<br>diagnosis. |
| 4.6 | Net weight | 5 kg (excluding the base) | 7.5 kg(without stand) | Different weight<br>due to different<br>components<br>and parts |
| 4.7 | VESA<br>standard | 100 x 100 (mm) | 100 x 100 (mm) | same |

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## 6.2 HMD3G21S and its predicate

Table 03: General Comparison Table

| Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Number | K222132 | K141690 | / |
| Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | / |
| Device<br>type/model | HMD3G21S | JUSHA-M33C | / |
| Intended use/<br>Indication for<br>use | The 3MP Monochrome LCD<br>Monitor HMD3G21S is<br>intended to be used in<br>displaying and viewing digital<br>images for diagnosis X-ray or<br>MRI, etc. by trained medical<br>practitioners.<br>The device does not support<br>the display of mammography<br>images for diagnosis. | JUSHA-M33C Monitor is<br>intended to be used in<br>displaying and viewing digital<br>images for diagnosis of X-ray or<br>MRI, etc. by trained medical<br>practitioners.<br>The device does not support the<br>display of mammography<br>images for diagnosis. | same |
| Prescription or<br>OTC | RX | RX | same |
| Electrical<br>Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | same |
| EMC | Compliance with IEC<br>60601-1-2 | Compliance with IEC 60601-1-2 | same |
| Performance<br>testing | FDA guidance "Display<br>devices for Dignostic<br>Radiology" | FDA guidance "Display devices<br>for Dignostic Radiology" | same |

Table 04: Detailed Comparison Table

| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
|-----------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| ID | 510(k) Number | K222132 | K141690 | - |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device type/model | HMD3G21S | JUSHA-M33C | - |
| 1.Display Performance/Specifications | | | | |
| 1.1 | Screen size | 21.3 inches (540 mm) | 21.3inches | same |
| 1.2 | Screen<br>Technology | Gray scale TFT LCD panel | Mono-TFT LCD Panel | same |
| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K141690 | - |
| ID | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device<br>type/model | HMD3G21S | JUSHA-M33C | - |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical:<br>178° (CR ≥ 10:1) | Horizontal 176°,Vertical<br>176° | the specification<br>of the proposed<br>device is<br>superior to that<br>of the predicate<br>device |
| 1.4 | Pixel array | 2048 pixels (H) x 1536<br>pixels (V) | 2048 x1536/1536x 2048 | same |
| 1.5 | Display Area | 433.15 (H) x 324.86 (V)<br>(mm) | 433.152 (H) x 324.864<br>(V) (mm) | same |
| 1.6 | Pixel Pitch | 0.2115 (H) x 0.2115 (V)<br>(mm) | 0.2115x0.2115 mm | same |
| 1.7 | Subpixel<br>driving | Not Applicable | Not Applicable | - |
| 1.8 | Contrast Ratio | 1500:1 (typ.) | 1400:1 | the specification<br>of the proposed<br>device is<br>superior to that<br>of the predicate<br>device |
| 1.9 | Frame Rate<br>and Refresh<br>Rate | 96.7kHz;60Hz | 96.7kHz;60Hz | same |
| 1.10 | Maximum<br>Brightness(typ<br>) | 2000cd/m² | 1700cd/m² | the specification<br>of the proposed<br>device is<br>superior to that<br>of the predicate<br>device |
| 1.11 | Recommende<br>d brightness | 500d/cm² | 500cd/m² | same |
| 1.12 | Backlight type | LED | LED | same |
| 1.13 | Ambient<br>light<br>sensing | Built-in ambient light<br>sensor | Built in calibration<br>sensor<br>provided | same |
| ID | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K141690 | - |
| ID | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device<br>type/model | HMD3G21S | JUSHA-M33C | - |
| 1.14 | Response<br>Time | 28 ms (typ.) | 40 ms | the specification<br>of the proposed<br>device is<br>superior to that<br>of the predicate<br>device |
| 1.15 | Aspect Ratio | 4:3 | 4:3 | same |
| 1.16 | Luminance<br>calibration | Front-facing sensor<br>Upper Computer Software<br>Body sensor | Built in calibration<br>sensor<br>provided | Same, only<br>difference in<br>words. |
| 1.17 | Touch-screen | Not Applicable | Not Applicable | - |
| 2.Video Signals | | | | |
| 2.1 | Input Video<br>Signal | DVI-D x 1<br>DisplayPort x 1 | DVI-D x 1<br>DisplayPort x 1 | same |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 | same |
| 2.3 | Video<br>bandwidth | DVI: 215MHz<br>DisplayPort : 215MHz | DVI: 215MHz<br>DisplayPort : 215MHz | same |
| 3.Power Related Specification | | | | |
| 3.1 | Power<br>Requirements | 24 V DC, 1.7 A | AC 100~240V 50~60Hz | this<br>difference<br>doesn't<br>affect<br>product's safety. |
| 3.2 | Power<br>Consumption/<br>save mode | 40.8 W/Below 0.5 W | 45W/less than 3W | this<br>difference<br>doesn't<br>affect<br>product's safety. |
| 3.3 | Power<br>Management | DVI DMPM<br>DisplayPort 1.2a | DVI DMPM<br>DisplayPort 1.1a | this difference<br>doesn't affect<br>product's safety. |
| 4.Miscellaneous Features/Specifications | | | | |
| 4.1 | USB ports | 1 uplink port and 2<br>downlink ports/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 | same |
| | Elements of<br>Comparison | Proposed device | Predicate Device | Remarks |
| ID | 510(k) Number | K222132 | K141690 | - |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | - |
| | Device<br>type/model | HMD3G21S | JUSHA-M33C | - |
| 4.2 | Grayscale<br>Tones(LUT) | 16384 | 65536 | Different design<br>scheme. The<br>difference does<br>not affect<br>diagnosis. |
| 4.3 | User controls | Off the shelf | Off the shelf | same |
| 4.4 | Software/Firm<br>ware: | Built-in embedded software | Built-in embedded<br>software | same |
| 4.5 | Dimensions<br>w/o stand<br>(W x H x D) | Without base:366 mm x<br>482 mm x 63 mm;<br>With base:366 mm x<br>502-616 mm x 244 mm | Without stand:382mm<br>x490mm x75mm<br>With stand:382mm<br>x533mm x238mm | Different design<br>scheme,<br>the<br>difference does<br>not<br>affect<br>diagnosis. |
| 4.6 | Net weight | 6 kg(excluding the base) | 7 kg(Without stand) | Different weight<br>due to different<br>components<br>and parts |
| 4.7 | VESA<br>standard | 100 x 100 (mm) | 100 x 100 (mm) | same |

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#### 510(k) Premarket Notification Submission

#### Discussion of Differences

#### About HMD2G21S and JUSHA-M260G

- 1) The proposed device is superior to that of the predicate device in Contrast Ratio, Maximum Brightness. The proposes device has better displaying image quality. And the predicate device is better than proposed device in Response Time, this difference doesn't affect diagnosis.
- 2) Because of different design scheme, the Power, Dimension and Net weight is not same. But this difference doesn't affect the diagnosis 。

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#### About HMD3G21S and JUSHA-M33C

- 1) The proposed device is superior to that of the predicate device in Viewing Angle, Contrast Ratio, Maximum Brightness. The proposes device has better displaying image quality. And the predicate device is better than proposed device in Response Time and Grayscale Tones, but this difference doesn't affect diagnosis.
- Because of different design scheme, the Power, Dimension and Net 2) weight is not same. But This difference doesn't affect the diagnosis.

#### 7.Bench testing:

The bench tests were performed on the proposed devices HMD2G21S, HMD3G21S in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline). The detail test item as below.

| Measurements Guidance | HMD2G21S | HMD3G21S |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| a. Spatial resolution | By reporting modulation<br>transfer function. | By reporting modulation<br>transfer function |
| b. Pixel defects (maximum<br>counts, allowed defect types,<br>and locations) | Maximum number<br>allowed for each type. | Maximum number allowed<br>for each type. |
| c. Artifacts | Measure Artifacts with<br>TG18 | Measure Artifacts with<br>TG18 |
| d. Temporal response | Measure the rise and fall<br>time constants for 5-95%<br>and 40-60% luminance<br>transitions. | Measure the rise and fall<br>time constants for 5-95%<br>and 40-60% luminance<br>transitions. |
| e. Luminance (maximum,<br>minimum, achievable, and<br>recommended) | Measure the maximum,<br>minimum, achievable, and<br>recommended luminance. | Measure the maximum,<br>minimum, achievable, and<br>recommended luminance. |
| f. Conformance to a<br>grayscale-to-luminance<br>function (e.g., DICOM GSDF) | Luminance Response by<br>AAPM-TG18. | Luminance Response by<br>AAPM-TG18. |
| g. Luminance at 30° and 45° in<br>diagonal, horizontal, and<br>vertical directions at center<br>and four corners | NA | NA |
| h. Luminance uniformity or<br>Mura test | NA | NA |
| i. Stability of luminance and<br>chromaticity response with<br>temperature and time of<br>operation or on-time | NA | NA |
| j. Spatial noise | NA | NA |
| k. Reflection coefficient | NA | NA |
| I. Veiling glare or small-spot<br>contrast | NA | NA |

{14}------------------------------------------------

#### 510(k) Premarket Notification Submission

| Measurements Guidance | HMD2G21S | HMD3G21S |
|-------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| m. Color tracking (primary<br>colors and color gamut) | NA, HMD2G21S is a<br>monochrome LCD<br>monitor, not color monitor | NA, HMD3G21S is a<br>monochrome LCD<br>monitor, not color monitor |
| n. Gray tracking (gray shades<br>and white point) | NA | NA |

## 8.Summary of Non-Clinical Tests

The Hisense LCD Monitor were evaluated for electrical, electromagnetic and performance, and have been found to comply with applicable standards as following:

(1) EN 60601-1:2006+A1:2013+A12:2014 & IEC60601-1:2005+CORR.1:2006+ CORR.2:2007+AM1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance

(2) IEC 60601-1-2:2014 & EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The following quality assurance measures are applied to the development of the system:

- (1) Risk Management
- (2) Requirement review and Design reviews
- (3) Integration testing
- (4) Performance testing
- (5) Safety testing

etc.

## 9.Clinical Testing

### Not applicable.

The subject of this premarket submission 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.

### 10.Conclusion

Hisense considers the LCD Monitor HMD2G21S, HMD3G21S to be as safe, as effective, and performance is substantially equivalent to the predicate device.