Hisense LCD monitor HMD2G21S, HMD3G21S

• K Number: K222132
• Device Name: Hisense LCD monitor HMD2G21S, HMD3G21S
• Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd
• Date Cleared: 2022-11-08 ( 112 days)
• Product Code: PGY
• Regulation Number: 892.2050

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 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.

Predicate Devices

K183497, K141690

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a medical display monitor and its intended use for viewing medical images. There is no mention of AI or ML capabilities, image processing beyond display standards (like DICOM), or any data sets or performance studies related to AI/ML algorithms.

Therapeutic

No
This device is a monitor intended for displaying medical images for diagnostic purposes, not for providing therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device 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 Description" also mentions it provides "medical diagnostic functions."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "LCD monitor," which is a hardware component. The intended use and performance studies also focus on the display characteristics of a physical monitor.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
• Device Function: The description clearly states the device is an LCD monitor intended for displaying and viewing digital images from various medical imaging modalities (X-ray, MRI, CT, etc.). It is a display device, not a device that analyzes biological specimens.
• Intended Use: The intended use is for trained medical practitioners to view images for diagnosis. This is a crucial distinction from analyzing biological samples.

The device is a medical imaging display, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

PGY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray or MRI, etc.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical practitioners

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 for HMD2G21S and HMD3G21S:
a. Spatial resolution: By reporting modulation transfer function.
b. Pixel defects: Maximum number allowed for each type.
c. Artifacts: Measure Artifacts with TG18
d. Temporal response: Measure the rise and fall time constants for 5-95% and 40-60% luminance transitions.
e. Luminance: Measure the maximum, minimum, achievable, and recommended luminance.
f. Conformance to a grayscale-to-luminance function: Luminance Response by AAPM-TG18.
g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners: NA
h. Luminance uniformity or Mura test: NA
i. Stability of luminance and chromaticity response with temperature and time of operation or on-time: NA
j. Spatial noise: NA
k. Reflection coefficient: NA
l. Veiling glare or small-spot contrast: NA
m. Color tracking (primary colors and color gamut): NA, HMD2G21S is a monochrome LCD monitor, not color monitor. NA, HMD3G21S is a monochrome LCD monitor, not color monitor.
n. Gray tracking (gray shades and white point): NA

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K183497, K141690

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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 ([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

4

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 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: Wu [e-mail]
Tel: [phone]
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

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

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510(k) Premarket Notification Submission

| Elements of

Comparison	Proposed device	Predicate Device	Remarks
Electrical
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
testing	FDA guidance "Display devices
for Dignostic Radiology"	FDA guidance "Display devices
for Dignostic Radiology"	same

Table 02: Detailed Comparison Table

| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
|-------------------------------|----------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| ID | 510(k) Number | K222132 | K183497 | - |
| ID | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| ID | Device
type/model | HMD2G21S | JUSHA-M260G LCD
Monitor | - |
| | 1.Display Performance/Specifications | | | |
| 1.1 | Screen size | 21,3 inches (540 mm) | 21.3" | same |
| 1.2 | Screen
Technology | Gray scale TFT LCD panel | Mono-TFT LCD Panel | same |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical:
178° (CR ≥ 10) | Horizontal 178°,Vertical
178° | same |
| 1.4 | Pixel array | 1600 pixels (H) x 1200
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
driving | Not Applicable | Not Applicable | - |
| 1.8 | Contrast Ratio | 1800:1 (typ.) | 1400:1 | the specification
of the proposed
device is
superior to that
of the predicate
device |
| 1.9 | Frame rate /
refresh rate | 37.975kHz;60Hz | 37.975kHz;60Hz | same |
| 1.10 | Maximum
Brightness(typ | 1900 cd/m² | 1000cd/m² | the specification
of the proposed |
| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K183497 | - |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| | Device
type/model | HMD2G21S | JUSHA-M260G LCD
Monitor | - |
| | | | | device is
superior to that
of the predicate
device |
| 1.11 | Recommende
d brightness
for | 400 cd/m² | 400cd/m² | same |
| 1.12 | Backlight type | LED | LED | same |
| 1.13 | Ambient
light
sensing | Built-in ambient light
sensor | Built in calibration sensor
provided | same |
| 1.14 | Response
Time | 19 ms | 16 ms | The difference
does not
affect diagnosis. |
| 1.15 | Aspect Ratio | 4:3 | 4:3 | same |
| 1.16 | Luminance
calibration | Front-facing sensor
Upper Computer Software | Built in calibration sensor
provided | Same, only
difference in
words. |
| 1.17 | Touch-screen | Not Applicable | Not Applicable | - |
| 2.Video Signals | | | | |
| 2.1 | Input Video
Signal | DVI-D x 1
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 | same |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 | same |
| 2.3 | Video
bandwidth | DVI: 215MHz
DisplayPort : 215MHz | DVI: 215MHz
DisplayPort : 215MHz | same |
| 3.Power Related Specification | | | | |
| 3.1 | Power
Requirements | 24 V DC, 2,1 A | DC 12V | this difference
doesn't affect
product's
safety. |
| 3.2 | Power
Consumption/
save mode | 50.4W/Below 0.5 W | 50W/less than 0.5W | this difference
doesn't affect
product's
safety. |
| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K183497 | - |
| ID | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| | Device
type/model | HMD2G21S | JUSHA-M260G LCD
Monitor | - |
| 3.3 | Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM
DisplayPort 1.1a | this difference
doesn't affect
product's
safety. |
| | | 4.Miscellaneous Features/Specifications | | |
| 4.1 | USB ports | 1 uplink port and 2
downlink ports/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | same |
| 4.2 | Grayscale
Tones(LUT) | 14-bit:16384 | 14-bit:16384 | same |
| 4.3 | User controls | Off the shelf | Off the shelf | same |
| 4.4 | Software/Firm
ware: | Built-in embedded
software | Built-in embedded
software | same |
| 4.5 | Dimensions
w/o stand
(W x H x D) | Without base:366 mm x
482 mm x 63 mm
With base:366 mm x
502-616 mm x 244 mm | Without stand: 382mm
x490mm x77mm
With stand: 382mm
x635mm x238mm | Different design
scheme, the
difference does
not affect
diagnosis. |
| 4.6 | Net weight | 5 kg (excluding the base) | 7.5 kg(without stand) | Different weight
due to different
components
and parts |
| 4.7 | VESA
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

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

Table 04: Detailed Comparison Table

| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
|-----------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| ID | 510(k) Number | K222132 | K141690 | - |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
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
Technology | Gray scale TFT LCD panel | Mono-TFT LCD Panel | same |
| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K141690 | - |
| ID | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| | Device
type/model | HMD3G21S | JUSHA-M33C | - |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical:
178° (CR ≥ 10:1) | Horizontal 176°,Vertical
176° | the specification
of the proposed
device is
superior to that
of the predicate
device |
| 1.4 | Pixel array | 2048 pixels (H) x 1536
pixels (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 | Subpixel
driving | Not Applicable | Not Applicable | - |
| 1.8 | Contrast Ratio | 1500:1 (typ.) | 1400:1 | the specification
of the proposed
device is
superior to that
of the predicate
device |
| 1.9 | Frame Rate
and Refresh
Rate | 96.7kHz;60Hz | 96.7kHz;60Hz | same |
| 1.10 | Maximum
Brightness(typ
) | 2000cd/m² | 1700cd/m² | the specification
of the proposed
device is
superior to that
of the predicate
device |
| 1.11 | Recommende
d brightness | 500d/cm² | 500cd/m² | same |
| 1.12 | Backlight type | LED | LED | same |
| 1.13 | Ambient
light
sensing | Built-in ambient light
sensor | Built in calibration
sensor
provided | same |
| ID | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
| | 510(k) Number | K222132 | K141690 | - |
| ID | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| | Device
type/model | HMD3G21S | JUSHA-M33C | - |
| 1.14 | Response
Time | 28 ms (typ.) | 40 ms | the specification
of the proposed
device is
superior to that
of the predicate
device |
| 1.15 | Aspect Ratio | 4:3 | 4:3 | same |
| 1.16 | Luminance
calibration | Front-facing sensor
Upper Computer Software
Body sensor | Built in calibration
sensor
provided | Same, only
difference in
words. |
| 1.17 | Touch-screen | Not Applicable | Not Applicable | - |
| 2.Video Signals | | | | |
| 2.1 | Input Video
Signal | DVI-D x 1
DisplayPort x 1 | DVI-D x 1
DisplayPort x 1 | same |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 | same |
| 2.3 | Video
bandwidth | DVI: 215MHz
DisplayPort : 215MHz | DVI: 215MHz
DisplayPort : 215MHz | same |
| 3.Power Related Specification | | | | |
| 3.1 | Power
Requirements | 24 V DC, 1.7 A | AC 100240V 5060Hz | this
difference
doesn't
affect
product's safety. |
| 3.2 | Power
Consumption/
save mode | 40.8 W/Below 0.5 W | 45W/less than 3W | this
difference
doesn't
affect
product's safety. |
| 3.3 | Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM
DisplayPort 1.1a | this difference
doesn't affect
product's safety. |
| 4.Miscellaneous Features/Specifications | | | | |
| 4.1 | USB ports | 1 uplink port and 2
downlink ports/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | same |
| | Elements of
Comparison | Proposed device | Predicate Device | Remarks |
| ID | 510(k) Number | K222132 | K141690 | - |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd | - |
| | Device
type/model | HMD3G21S | JUSHA-M33C | - |
| 4.2 | Grayscale
Tones(LUT) | 16384 | 65536 | Different design
scheme. The
difference does
not affect
diagnosis. |
| 4.3 | User controls | Off the shelf | Off the shelf | same |
| 4.4 | Software/Firm
ware: | Built-in embedded software | Built-in embedded
software | same |
| 4.5 | Dimensions
w/o stand
(W x H x D) | Without base:366 mm x
482 mm x 63 mm;
With base:366 mm x
502-616 mm x 244 mm | Without stand:382mm
x490mm x75mm
With stand:382mm
x533mm x238mm | Different design
scheme,
the
difference does
not
affect
diagnosis. |
| 4.6 | Net weight | 6 kg(excluding the base) | 7 kg(Without stand) | Different weight
due to different
components
and parts |
| 4.7 | VESA
standard | 100 x 100 (mm) | 100 x 100 (mm) | same |

10

11

12

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 。

13

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

14

510(k) Premarket Notification Submission

Measurements Guidance	HMD2G21S	HMD3G21S
m. Color tracking (primary
colors and color gamut)	NA, HMD2G21S is a
monochrome LCD
monitor, not color monitor	NA, HMD3G21S is a
monochrome LCD
monitor, not color monitor
n. Gray tracking (gray shades
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.