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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Hisense LCD monitors (HMD2G21S, HMD3G21S), based on the provided document.

It's important to note that this document, a 510(k) Premarket Notification, primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way a novel diagnostic algorithm might. In this case, the "acceptance criteria" largely refer to compliance with technical standards and equivalence to existing cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

For medical display monitors, the "acceptance criteria" are generally based on meeting industry standards for display performance for diagnostic radiology. The reported device performance is presented as compliance with these standards and comparison to predicate devices.

Acceptance Criteria (Guidance/Standard)	Applicable Device	Reported Device Performance
General Safety and EMC	HMD2G21S, HMD3G21S	Compliance with IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) and EN 60601-1:2006+A1:2013+A12:2014
	HMD2G21S, HMD3G21S	Compliance with IEC 60601-1-2:2014 & EN 60601-1-2:2015 (Medical electrical equipment - Part 1-2: Electromagnetic disturbances - Requirements and tests)
Display Performance (AAPM TG18 / FDA Guidance)	HMD2G21S, HMD3G21S	Bench tests performed in accordance with "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)" and FDA guidance "Display devices for Diagnostic Radiology". Specific tests include:
- Spatial resolution (Modulation Transfer Function)	HMD2G21S, HMD3G21S	Reported.
- Pixel defects (maximum counts, allowed types, locations)	HMD2G21S, HMD3G21S	Reported as "Maximum number allowed for each type."
- Artifacts (using TG18)	HMD2G21S, HMD3G21S	Measured.
- Temporal response (rise/fall time for 5-95% and 40-60% luminance transitions)	HMD2G21S, HMD3G21S	Measured.
- Luminance (maximum, minimum, achievable, recommended)	HMD2G21S, HMD3G21S	Measured.
- Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF)	HMD2G21S, HMD3G21S	Luminance Response by AAPM-TG18.

Specific quantitative performance metrics (e.g., exact measured contrast ratio, brightness, or MTF values) are indicated as "reported" or "measured" in the testing section, but the actual numerical results are not provided in this summary. The comparison tables (Table 02 and Table 04) show that the proposed devices meet or exceed the performance specifications of the predicate devices for key display parameters like contrast ratio and maximum brightness.

2. Sample Size Used for the Test Set and Data Provenance

This submission is for a medical display monitor, not a diagnostic algorithm that processes medical image data. Therefore, there is no "test set" of medical images or patient data in the conventional sense for evaluating diagnostic performance. The testing involved evaluating the physical and electrical characteristics of the monitors themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As described above, there is no "test set" of medical images requiring expert-established ground truth for diagnostic performance evaluation for a display monitor. The testing involves objective measurements of display characteristics against technical standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is for a display monitor, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a display monitor, not a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a display monitor is its physical and electrical characteristics conforming to established technical standards (like DICOM Part 14 and AAPM TG18 guidelines), not a clinical diagnosis or outcome.

8. The Sample Size for the Training Set

Not applicable. This is a physical device (monitor), not a software algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.

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.Address: No. 399 Songling Road, Laoshan District266100, Qingdao, Shandong, P. R. China
Contact Person:	Primary Contact PersonLu zhonghaoQuality EngineerQingdao Hisense Medical Equipment Co.,Ltd.Mail:luzhonghao@hisense.comTel: +86-532-83091111Fax:+86-532-83091111Secondary Contact PersonWu yalanRA ManagerQingdao Hisense Medical Equipment Co.,Ltd.Mail: Wu yalan@hisense.comTel: +86-532-83091111Fax:+86-532-83091111

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

5. Intended Use/Indication for Use

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.

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 ofComparison	Proposed device	Predicate Device	Remarks
510(k)Number	K222132	K183497	-
Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
Devicetype/model	HMD2G21S	JUSHA-M260G LCD Monitor	-
Intendeduse/Indication foruse	The 2MP Monochrome LCDMonitor HMD2G21S is intendedto be used in displaying andviewing digital images fordiagnosis of X-ray or MRI, etc.by trained medical practitioners.The device does not support thedisplay of mammographyimages for diagnosis.	JUSHA-M260G LCD Monitor isintended to be used indisplaying and viewing digitalimages for diagnosis of X-ray orMRI, etc. by trained medicalpractitioners.The device does not support thedisplay of mammographyimages for diagnosis.	same
Prescriptionor OTC	RX	RX	same

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510(k) Premarket Notification Submission

Elements ofComparison	Proposed device	Predicate Device	Remarks
ElectricalSafety	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
Performancetesting	FDA guidance "Display devicesfor Dignostic Radiology"	FDA guidance "Display devicesfor Dignostic Radiology"	same

Table 02: Detailed Comparison Table

	Elements ofComparison	Proposed device	Predicate Device	Remarks
ID	510(k) Number	K222132	K183497	-
ID	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
ID	Devicetype/model	HMD2G21S	JUSHA-M260G LCDMonitor	-
	1.Display Performance/Specifications
1.1	Screen size	21,3 inches (540 mm)	21.3"	same
1.2	ScreenTechnology	Gray scale TFT LCD panel	Mono-TFT LCD Panel	same
1.3	Viewing Angle	Horizontal: 178°; vertical:178° (CR ≥ 10)	Horizontal 178°,Vertical178°	same
1.4	Pixel array	1600 pixels (H) x 1200pixels (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	Subpixeldriving	Not Applicable	Not Applicable	-
1.8	Contrast Ratio	1800:1 (typ.)	1400:1	the specificationof the proposeddevice issuperior to thatof the predicatedevice
1.9	Frame rate /refresh rate	37.9~75kHz;60Hz	37.9~75kHz;60Hz	same
1.10	MaximumBrightness(typ	1900 cd/m²	1000cd/m²	the specificationof the proposed
	Elements ofComparison	Proposed device	Predicate Device	Remarks
	510(k) Number	K222132	K183497	-
	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
	Devicetype/model	HMD2G21S	JUSHA-M260G LCDMonitor	-
				device issuperior to thatof the predicatedevice
1.11	Recommended brightnessfor	400 cd/m²	400cd/m²	same
1.12	Backlight type	LED	LED	same
1.13	Ambientlightsensing	Built-in ambient lightsensor	Built in calibration sensorprovided	same
1.14	ResponseTime	19 ms	16 ms	The differencedoes notaffect diagnosis.
1.15	Aspect Ratio	4:3	4:3	same
1.16	Luminancecalibration	Front-facing sensorUpper Computer Software	Built in calibration sensorprovided	Same, onlydifference inwords.
1.17	Touch-screen	Not Applicable	Not Applicable	-
2.Video Signals
2.1	Input VideoSignal	DVI-D x 1DisplayPort x 1	DVI-D x 1,DisplayPort x 1	same
2.2	Output Signal	DisplayPort x 1	DisplayPort x1	same
2.3	Videobandwidth	DVI: 215MHzDisplayPort : 215MHz	DVI: 215MHzDisplayPort : 215MHz	same
3.Power Related Specification
3.1	PowerRequirements	24 V DC, 2,1 A	DC 12V	this differencedoesn't affectproduct'ssafety.
3.2	PowerConsumption/save mode	50.4W/Below 0.5 W	50W/less than 0.5W	this differencedoesn't affectproduct'ssafety.
	Elements ofComparison	Proposed device	Predicate Device	Remarks
	510(k) Number	K222132	K183497	-
ID	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
	Devicetype/model	HMD2G21S	JUSHA-M260G LCDMonitor	-
3.3	PowerManagement	DVI DMPMDisplayPort 1.2a	DVI DMPMDisplayPort 1.1a	this differencedoesn't affectproduct'ssafety.
		4.Miscellaneous Features/Specifications
4.1	USB ports	1 uplink port and 2downlink ports/ Rev. 2.0	1 upstream (endpoint),2 downstream/ Rev. 2.0	same
4.2	GrayscaleTones(LUT)	14-bit:16384	14-bit:16384	same
4.3	User controls	Off the shelf	Off the shelf	same
4.4	Software/Firmware:	Built-in embeddedsoftware	Built-in embeddedsoftware	same
4.5	Dimensionsw/o stand(W x H x D)	Without base:366 mm x482 mm x 63 mmWith base:366 mm x502-616 mm x 244 mm	Without stand: 382mmx490mm x77mmWith stand: 382mmx635mm x238mm	Different designscheme, thedifference doesnot affectdiagnosis.
4.6	Net weight	5 kg (excluding the base)	7.5 kg(without stand)	Different weightdue to differentcomponentsand parts
4.7	VESAstandard	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 ofComparison	Proposed device	Predicate Device	Remarks
510(k) Number	K222132	K141690	/
Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	/
Devicetype/model	HMD3G21S	JUSHA-M33C	/
Intended use/Indication foruse	The 3MP Monochrome LCDMonitor HMD3G21S isintended to be used indisplaying and viewing digitalimages for diagnosis X-ray orMRI, etc. by trained medicalpractitioners.The device does not supportthe display of mammographyimages for diagnosis.	JUSHA-M33C Monitor isintended to be used indisplaying and viewing digitalimages for diagnosis of X-ray orMRI, etc. by trained medicalpractitioners.The device does not support thedisplay of mammographyimages for diagnosis.	same
Prescription orOTC	RX	RX	same
ElectricalSafety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	same
EMC	Compliance with IEC60601-1-2	Compliance with IEC 60601-1-2	same
Performancetesting	FDA guidance "Displaydevices for DignosticRadiology"	FDA guidance "Display devicesfor Dignostic Radiology"	same

Table 04: Detailed Comparison Table

	Elements ofComparison	Proposed device	Predicate Device	Remarks
ID	510(k) Number	K222132	K141690	-
	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology 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	ScreenTechnology	Gray scale TFT LCD panel	Mono-TFT LCD Panel	same
	Elements ofComparison	Proposed device	Predicate Device	Remarks
	510(k) Number	K222132	K141690	-
ID	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
	Devicetype/model	HMD3G21S	JUSHA-M33C	-
1.3	Viewing Angle	Horizontal: 178°; vertical:178° (CR ≥ 10:1)	Horizontal 176°,Vertical176°	the specificationof the proposeddevice issuperior to thatof the predicatedevice
1.4	Pixel array	2048 pixels (H) x 1536pixels (V)	2048 x1536/1536x 2048	same
1.5	Display Area	433.15 (H) x 324.86 (V)(mm)	433.152 (H) x 324.864(V) (mm)	same
1.6	Pixel Pitch	0.2115 (H) x 0.2115 (V)(mm)	0.2115x0.2115 mm	same
1.7	Subpixeldriving	Not Applicable	Not Applicable	-
1.8	Contrast Ratio	1500:1 (typ.)	1400:1	the specificationof the proposeddevice issuperior to thatof the predicatedevice
1.9	Frame Rateand RefreshRate	96.7kHz;60Hz	96.7kHz;60Hz	same
1.10	MaximumBrightness(typ)	2000cd/m²	1700cd/m²	the specificationof the proposeddevice issuperior to thatof the predicatedevice
1.11	Recommended brightness	500d/cm²	500cd/m²	same
1.12	Backlight type	LED	LED	same
1.13	Ambientlightsensing	Built-in ambient lightsensor	Built in calibrationsensorprovided	same
ID	Elements ofComparison	Proposed device	Predicate Device	Remarks
	510(k) Number	K222132	K141690	-
ID	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
	Devicetype/model	HMD3G21S	JUSHA-M33C	-
1.14	ResponseTime	28 ms (typ.)	40 ms	the specificationof the proposeddevice issuperior to thatof the predicatedevice
1.15	Aspect Ratio	4:3	4:3	same
1.16	Luminancecalibration	Front-facing sensorUpper Computer SoftwareBody sensor	Built in calibrationsensorprovided	Same, onlydifference inwords.
1.17	Touch-screen	Not Applicable	Not Applicable	-
2.Video Signals
2.1	Input VideoSignal	DVI-D x 1DisplayPort x 1	DVI-D x 1DisplayPort x 1	same
2.2	Output Signal	DisplayPort x 1	DisplayPort x1	same
2.3	Videobandwidth	DVI: 215MHzDisplayPort : 215MHz	DVI: 215MHzDisplayPort : 215MHz	same
3.Power Related Specification
3.1	PowerRequirements	24 V DC, 1.7 A	AC 100~~240V 50~~60Hz	thisdifferencedoesn'taffectproduct's safety.
3.2	PowerConsumption/save mode	40.8 W/Below 0.5 W	45W/less than 3W	thisdifferencedoesn'taffectproduct's safety.
3.3	PowerManagement	DVI DMPMDisplayPort 1.2a	DVI DMPMDisplayPort 1.1a	this differencedoesn't affectproduct's safety.
4.Miscellaneous Features/Specifications
4.1	USB ports	1 uplink port and 2downlink ports/ Rev. 2.0	1 upstream (endpoint),2 downstream/ Rev. 2.0	same
	Elements ofComparison	Proposed device	Predicate Device	Remarks
ID	510(k) Number	K222132	K141690	-
	Manufacturer	Qingdao Hisense MedicalEquipment Co., Ltd	Nanjing Jusha DisplayTechnology Co., Ltd	-
	Devicetype/model	HMD3G21S	JUSHA-M33C	-
4.2	GrayscaleTones(LUT)	16384	65536	Different designscheme. Thedifference doesnot affectdiagnosis.
4.3	User controls	Off the shelf	Off the shelf	same
4.4	Software/Firmware:	Built-in embedded software	Built-in embeddedsoftware	same
4.5	Dimensionsw/o stand(W x H x D)	Without base:366 mm x482 mm x 63 mm;With base:366 mm x502-616 mm x 244 mm	Without stand:382mmx490mm x75mmWith stand:382mmx533mm x238mm	Different designscheme,thedifference doesnotaffectdiagnosis.
4.6	Net weight	6 kg(excluding the base)	7 kg(Without stand)	Different weightdue to differentcomponentsand parts
4.7	VESAstandard	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.
1. 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 modulationtransfer function.	By reporting modulationtransfer function
b. Pixel defects (maximumcounts, allowed defect types,and locations)	Maximum numberallowed for each type.	Maximum number allowedfor each type.
c. Artifacts	Measure Artifacts withTG18	Measure Artifacts withTG18
d. Temporal response	Measure the rise and falltime constants for 5-95%and 40-60% luminancetransitions.	Measure the rise and falltime constants for 5-95%and 40-60% luminancetransitions.
e. Luminance (maximum,minimum, achievable, andrecommended)	Measure the maximum,minimum, achievable, andrecommended luminance.	Measure the maximum,minimum, achievable, andrecommended luminance.
f. Conformance to agrayscale-to-luminancefunction (e.g., DICOM GSDF)	Luminance Response byAAPM-TG18.	Luminance Response byAAPM-TG18.
g. Luminance at 30° and 45° indiagonal, horizontal, andvertical directions at centerand four corners	NA	NA
h. Luminance uniformity orMura test	NA	NA
i. Stability of luminance andchromaticity response withtemperature and time ofoperation or on-time	NA	NA
j. Spatial noise	NA	NA
k. Reflection coefficient	NA	NA
I. Veiling glare or small-spotcontrast	NA	NA

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510(k) Premarket Notification Submission

Measurements Guidance	HMD2G21S	HMD3G21S
m. Color tracking (primarycolors and color gamut)	NA, HMD2G21S is amonochrome LCDmonitor, not color monitor	NA, HMD3G21S is amonochrome LCDmonitor, not color monitor
n. Gray tracking (gray shadesand 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.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).