Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D

K222208 · Qingdao Hisense Medical Equipment Co., Ltd. · PGY · Nov 17, 2022 · Radiology

Device Facts

• Record ID: K222208
• Device Name: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
• Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

Device Story

Hisense LCD monitors (HMD2C21A, HMD4C27S, HMD6C30D) are high-resolution color diagnostic displays; input signals via DVI-D, DisplayPort, or HDMI; output radiological images for clinical review and diagnosis. Used in clinical environments by trained medical practitioners. Features include ambient light induction, front-facing sensor calibration, and energy-saving modes (body-inductive energy-saving/auto-awake for HMD4C27S/HMD6C30D). Monitors utilize internal LUTs to ensure DICOM GSDF compliance for image consistency. Devices assist clinicians in viewing medical images; do not support mammography.

Clinical Evidence

No clinical data or animal studies were required or provided. Substantial equivalence is supported by bench testing conducted in accordance with AAPM Task Group 18 (TG18) guidelines, including spatial resolution, pixel defects, artifacts, temporal response, luminance, DICOM GSDF conformance, and color tracking.

Technological Characteristics

Color LCD (IPS) panels; LED backlight; resolutions 1600x1200 (HMD2C21A), 2560x1440 (HMD4C27S), 3280x2080 (HMD6C30D). Features: ambient light sensor, front-facing calibration sensor, DICOM-compliant LUT. Connectivity: DVI-D, DisplayPort, HDMI, USB 2.0. Compliance: IEC 60601-1, IEC 60601-1-2. Embedded software for OSD, monitor control, and quality control.

Indications for Use

Indicated for trained medical practitioners for the display, review, analysis, and diagnosis of radiological images. Not indicated for mammography image display.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• JUSHA-C 270G (K183498)
• C44W+ (K202374)
• RadiForce RX660 (K163335)

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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

November 17, 2022

### Re: K222208

Trade/Device Name: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D 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 18, 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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. 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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K222208

#### Device Name Hisense

LCD monitor( HMD2C21A,HMD4C27S,HMD6C30D)

Indications for Use (Describe)

These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.

| Type of Use (Select one or both, as applicable) | <table><tr><td><span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"><b>X</b></div> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr><tr><td><span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"></div> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"><b>X</b></div> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"></div> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"><b>X</b></div> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | |
| <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;"> <div style="text-align:center;"></div> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | | |

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## Section5: 510(k) Summary

## (K22208)

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

| Date | Oct. 7, 2022 | | | | |
|----------------------|-----------------------------------------------------|-----------------|---------------|--------------|----------------------------------------------|
| Submitter | Qingdao Hisense Medical Equipment Co.,Ltd. | | | | |
| | Address: No. 399 Songling Road, Laoshan District | | | | |
| | 266100, Qingdao, Shandong, P. R. China | | | | |
| Contact Person: | Primary Contact Person | | | | |
| | Lu zhonghao | | | | |
| | Quality Engineer | | | | |
| | Qingdao Hisense Medical Equipment Co. Ltd. | | | | |
| | Mail:[e-mail] | | | | |
| | Tel: [phone] | | | | |
| | Fax:[phone] | | | | |
| | Secondary Contact Person | | | | |
| | Wu yalan | | | | |
| | RA Manager | | | | |
| | Qingdao Hisense Medical Equipment Co. Ltd. | | | | |
| | Mail: [e-mail] | | | | |
| | Tel: [phone] | | | | |
| | Fax:[phone] | | | | |
| Device Trade Name: | Hisense LCD monitor HMD2C21A, HMD4C27S,<br>HMD6C30D | | | | |
| Common/Usual Name: | 2M/4M/6M Color LCD monitor | | | | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | | | | |
| Product Code: | PGY | | | | |
| | N<br>o. | Trade Name | 510(k) Number | Product Code | Manufacturer |
| Predicate Device(s): | 1 | JUSHA-C 270G | K183498 | PGY | Nanjing Jusha Display Technology Co., Ltd |
| | 2 | C44W+ | K202374 | PGY | shenzhen Beacon Display Technology Co., Ltd. |
| | 3 | RadiForce RX660 | K163335 | PGY | EIZO Corporation |

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| Device Description: | The Hisense LCD monitors are intended for<br>trained medical practitioners and provides the<br>image viewing and medical diagnostic functions.<br>HMD2C21A, HMD4C27S, HMD6C30D are<br>developed with different resolution:1600 x 1200,<br>2560 x 1440, 3280 × 2080. So the LCD monitors<br>can be used in different environment according to<br>different resolution requirement.<br>The three models also developed with same<br>features such as energy saving, ambient light<br>induction, front-facing sensor calibration, etc. In<br>particular, HMD4C27S, HMD6C30D have<br>body-inductive energy-saving and auto awake<br>function.<br>The Hisense LCD monitor complies with<br>standards as following:<br>1. EN 60601-1:2006+A1:2013+A12:2014 &<br>IEC60601-1:2005+CORR.1:2006+CORR.2:2007<br>+AM1:2012 Medical electrical equipment<br>Part 1: General requirements for basic safety and<br>essential performance<br>2. IEC 60601-1-2:2014 & EN 60601-1-2:2015<br>Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and<br>tests. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | These products are intended to be used in<br>displaying radiological images for review, analysis<br>and diagnosis by trained medical practitioners.<br>They do not support the display of mammography<br>images for diagnosis. |
| Technology: | 1)HMD2C21A is a 2M color LCD diagnostic<br>monitor. It strictly complies with the DICOM<br>standard and has the features of high-resolution,<br>high-brightness display. It uses OSD menu<br>software, monitor control software, and quality<br>control software to achieve functional stability.<br>2) HMD4S27S is a 4M color, one-screen and<br>dual-display diagnostic monitor. It strictly complies<br> |
| Determination of Substantial<br>Equivalence: | with the DICOM standard and integrates the<br>functions of image browsing, reading and writing<br>clinical reports, etc. It uses OSD menu software,<br>monitor control software, and quality control<br>software to achieve functional stability.<br>3)HMD6C30D is a 6M color, one-screen and<br>dual-display diagnostic monitor. The built-in<br>DICOM standard LUT ensures the long-term<br>stability and consistency of the display, and truly<br>restores the original information of the image. It<br>uses OSD menu software, monitor control<br>software, and quality control software to achieve<br>functional stability. |
| | <b>Summary of Non-Clinical Tests:</b><br>The Hisense LCD monitor (HMD2C21A,<br>HMD4C27S, HMD6C30D) complies with<br>standards as following:<br>1. EN 60601-1:2006+A1:2013+A12:2014 &<br>IEC60601-1:2005+CORR.1:2006+CORR.2:2007<br>+AM1:2012 Medical electrical equipment Part 1:<br>General requirements for basic safety and<br>essential performance<br>2. IEC 60601-1-2:2014 & EN 60601-1-2:2015<br>Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and<br>tests.<br>The Hisense LCD monitor HMD2C21A,<br>HMD4C27S, HMD6C30D are substantially<br>equivalent to JUSHA-C270G, C44W+, RadiForce<br>RX660. They have equivalent characteristics and<br>functions according to comparison table, please<br>refer to 2. Product Comparison<br>The following quality assurance measures were<br>applied to the development of the system:<br>·Electrical Safety & EMC test<br>·Performance test |
| | Risk Management & Analysis Design Reviews Raw materials verification Final acceptance test etc. <b>Summary of Clinical Tests:</b><br>The subject of this premarket submission,<br>Hisense LCD monitor, don't require clinical<br>studies to support substantial equivalence.<br>The proposed device is Substantially Equivalent<br>(SE) to the predicate device which is US legally<br>market device. Therefore, the subject device is<br>determined as safe and effectiveness. |
| <b>Conclusion</b> | Qingdao Hisense Medical Equipment Co., Ltd.<br>Considers the Hisense HMD2C21A, HMD4C27S<br>and HMD6C30D LCD monitor to be as safe, as<br>effective, and performance is substantially<br>equivalent to the predicate devices. |

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### 2 Product Comparison

This comparison identifies the similarities and differences of the proposed HMD2 C21A, HMD4C27S and HMD6C30D LCD monitor device to the legally marketed predicate JUSHA-C270G, C44W+ and RadiForce RX660 LCD Monitor.

## 2.1 HMD2C21A and its predicate

Tabel1 HMD2C21A Detailed Comparison with Predicate

| | Elements of<br>Comparison | Proposed device | Predicate Device | | | |
|--------------------------------------|---------------------------|-----------------------------------------------|----------------------------------------------|--|--|--|
| ID | 510(k) Number | K222208 | K183498 | | | |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd | | | |
| | Device<br>type/model | HMD2C21A | JUSHA-C270G | | | |
| 1.Display Performance/Specifications | | | | | | |
| 1.1 | Screen size | 21,3 inches (540 mm) | 21.3" | | | |
| 1.2 | Screen<br>Technology | Color LCD panel (IPS) | Color TFT LCD Panel | | | |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°<br>(CR ≥ 10) | Horizontal 178°, Vertical 178° | | | |
| 1.4 | Pixel array | 1600 pixels (H) x 1200 pixels<br>(V) | 1600 x 1200/1200 x 1600 | | | |

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| ID | Elements of<br>Comparison | Proposed device | Predicate Device |
|---------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Number | K222208 | K183498 |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd |
| | Device<br>type/model | HMD2C21A | JUSHA-C270G |
| 1.5 | Display Area | 432 (H) x 324 (V) (mm) | 432.0 (H) x 324.0(V) mm |
| 1.6 | Pixel Pitch | 0.270 (H) x 0.270 (V) (mm) | 0.270x0.270 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 1800:1 (typ.) | 1400:1 |
| 1.9 | Frame rate | 60Hz | 37.9~75kHz;60Hz |
| 1.10 | Maximum<br>Brightness(typ) | 1000 cd/m² | 1000cd/m² |
| 1.11 | Recommended<br>brightness | 400cd/m² | 350cd/m² |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambient<br>light<br>sensing | Built-in ambient light sensor | Ambient luminance<br>self-adaptation(ABA) |
| 1.14 | Response Time | 16 ms (typ.) | 16 ms(8ms+8ms) |
| 1.15 | Aspect Ratio | 4:3 | 4:3 |
| 1.16 | Luminance<br>calibration | Front-facing sensor<br>Upper Computer Software | Built in calibration sensor<br>provided |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| 2.Video Signals | | | |
| 2.1 | Input<br>Video<br>Signal | DVI-D x 1<br>DisplayPort x 1 | DVI-D x 1,<br>DisplayPort x 1 |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 |
| 2.3 | Video bandwidth | DVI: 215MHz<br>DisplayPort : 215MHz | DVI: 215MHz<br>DisplayPort : 215MHz |
| 3.Power Related Specification | | | |
| 3.1 | Power<br>Requirements | 24 V DC, 1.9A | DC 24V |
| 3.2 | Power<br>Consumption/<br>save mode | 45.6W/Below 1W | 50W/less than 0.5W |
| 3.3 | Power<br>Management | DVI DMPM<br>DisplayPort 1.2a | DVI DMPM<br>DisplayPort 1.1a |
| 4.Miscellaneous Features/Specifications | | | |
| ID | Elements of<br>Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K183498 |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | Nanjing Jusha Display<br>Technology Co., Ltd |
| | Device<br>type/model | HMD2C21A | JUSHA-C270G |
| 4.1 | USB ports | 1 uplink port and<br>2 downlink ports/ Rev. 2.0 | 1 upstream (endpoint),<br>2 downstream/ Rev. 2.0 |
| 4.2 | Display color | 10bit | 16-bit |
| 4.3 | User controls | Off the shelf | Off the shelf |
| 4.4 | Software/Firmwar<br>e: | Built-in embedded software | Built-in embedded software |
| 4.5 | Dimensions w/o<br>stand<br>(W x H x D) | Without base:384 mm x 492<br>mm x 70mm<br>With base:384 mm x<br>517.5-637.5 mm x 273.5 mm | Without stand: 382mm<br>x490mm x77mm<br>With stand: 382mm x635mm<br>x238mm |
| 4.6 | Net weight | 4.3 kg (excluding the base) | 7.5 kg(without stand) |
| 4.7 | VESA standard | 100 x 100 (mm) | 100 x 100 (mm) |
| | | 5. Intended use | |
| 5.1 | Indication for use | This product is intended to be<br>used in displaying radiological<br>images for review, analysis and<br>diagnosis by trained<br>medical practitioners.<br><br>The product does not support<br>the display of mammography<br>images for diagnosis. | JUSHA-C270G LCD Monitor<br>is intended to be used in<br>displaying and viewing digital<br>images for diagnosis of X-ray<br>or MRI, etc. by trained<br>medical practitioners.<br><br>The device does not support<br>the display of mammography<br>images for diagnosis. |
| 6 Applicable standard | | | |
| 6.1 | Applicable<br>standard | Compliance with IEC 60601-1<br>Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1<br>Compliance with IEC 60601-1-2 |
| ID | Elements of<br>Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K202374 |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | shenzhen Beacon Display<br>Technology Co., Ltd. |
| | Device<br>type/model | HMD4C27S | C44W+ |
| <b>1.Display Performance/Specifications</b> | | | |
| 1.1 | Screen size | 27-inch | 772 mm (30.4") |
| 1.2 | Screen<br>Technology | Color LCD panel (IPS) | TFT LCD panel |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°<br>(CR ≥ 10:1) (typ.) | H:178°, V:178°,<br>(CR>10) |
| 1.4 | Pixel array | 2560 x 1440 | 4MP(2560 x 1600) |
| 1.5 | Display Area | 596.74 (H) x 335.66 (V) (mm) | 641.28 (H) x 400.8 (V) mm |
| 1.6 | Pixel Pitch | 0.2331 x0. 2331 (mm) | 0.2505 x 0.2505 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 1000:1 (typ.) | 1000:1 |
| 1.9 | Frame rate /<br>refresh rate | 49-76Hz,71.3~112.6kH | 31~140kHz, 29-60Hz |
| 1.10 | Maximum<br>Brightness(typ) | 550cd/m² | 700cd/m² |
| 1.11 | Recommended<br>brightness | 400 cd/m² | 500cd/m² |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambient<br>light<br>sensing | Built-in ambient light sensor | Yes |
| 1.14 | Response Time | 16 ms (typ.) | 6ms |
| 1.15 | Aspect Ratio | 16:10 | 16:10 |
| 1.16 | Luminance<br>non-uniformity<br>compensation | Not Applicable | Not Applicable |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| <b>2.Video Signals</b> | | | |
| 2.1 | Input Video<br>Signal | DVI-D x 2<br>DisplayPort x 2<br>HDMI | DVI-D x 2<br>DisplayPort x 2<br>VGA×1 |
| 2.2 | Output Signal | DisplayPort | NA |
| ID | Elements of<br>Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K202374 |
| | Manufacturer | Qingdao Hisense Medical<br>Equipment Co., Ltd | shenzhen Beacon Display<br>Technology Co., Ltd. |
| | Device<br>type/model | HMD4C27S | C44W+ |
| 2.3 | Video bandwidth | DVI: 215MHz<br>DisplayPort : 215MHz | DVI: 215MHz<br>DisplayPort : 215MHz |
| | | 3.Power Related Specification | |
| 3.1 | Power<br>Requirements | 24 V DC, 6.25A | DC 24 V/9A |
| 3.2 | Power<br>Consumption/<br>save mode | 70W/Below 0.5W | 80W/ less than 5W |
| 3.3 | Power<br>Management | DVI DMPM<br>DisplayPort 1.2a | DVI DMPM,<br>DisplayPort 1.2a |
| 4.Miscellaneous Features/Specifications | | | |
| 4.1 | USB ports | 1 uplink port and<br>2 downlink ports/ Rev. 2.0 | 1 upstream<br>2 downstream/ Rev. 2.0 |
| 4.2 | Display color | 8bit | 10-bit,<br>1,073,741,824color |
| 4.3 | Software/Firmwa<br>re: | Built-in embedded software | Built-in embedded software |
| 4.4 | Dimensions w/o<br>stand<br>(W x H x D) | Without base:653.8 mm x<br>520mm x 60mm<br>With base: 653.8 mm x<br>400mm x 60 mm | 699.3 x 513-633 x251.4mm<br>Without packing<br>864 x600 x334mm(with<br>packing) |
| 4.5 | Net weight | 8.5 kg (excluding the base) | 13±0.5kg(wet) |
| 4.6 | VESA standard | 100 x 100 (mm) | VESA (100 mm) |
| 5. Intended use | | | |
| 5.1 | Indication for use | This product is intended to be<br>used in displaying radiological<br>images for review, analysis<br>and diagnosis by trained<br>medical practitioners. The<br>product does not support the<br>display<br>of<br>mammography | These products are intended<br>to be used in displaying and<br>viewing digital images for<br>review and analysis by<br>trained medical practitioners.<br>They do not support the<br>displaying of mammography |
| | Elements of<br>Comparison…