Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical characteristics and display capabilities of LCD monitors, with no mention of AI or ML algorithms for image analysis or processing. The performance studies are limited to bench testing of display performance and electrical safety.

Therapeutic

No
The device is described as an LCD monitor for displaying radiological images for diagnosis, not for providing therapy.

Diagnostic

Yes

The device description explicitly states that the monitors provide "medical diagnostic functions."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an LCD monitor and describes hardware features and testing (bench testing, electrical safety, EMC testing) performed on the physical monitors.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The description clearly states that these devices are "intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners." They are monitors that display images generated by other medical imaging equipment (like X-ray, CT, MRI).
No Sample Testing: There is no mention of the device interacting with or analyzing biological samples. Its function is solely to display images.

Therefore, based on the provided information, the Hisense LCD monitors described are medical imaging display devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

PGY

Device Description

The Hisense LCD monitors are intended for trained medical practitioners and provides the image viewing and medical diagnostic functions. HMD2C21A, HMD4C27S, HMD6C30D are developed with different resolution:1600 x 1200, 2560 x 1440, 3280 × 2080. So the LCD monitors can be used in different environment according to different resolution requirement. The three models also developed with same features such as energy saving, ambient light induction, front-facing sensor calibration, etc. In particular, HMD4C27S, HMD6C30D have body-inductive energy-saving and auto awake function. The Hisense LCD monitor complies with 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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

The bench tests were performed on the proposed devices HMD2C21A, HMD4C27S, HMD6C30D in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline). Bench testing was conducted to demonstrate the HMD2C21A, HMD4C27S, HMD6C30D meets all performance standards as follows: Spatial resolution, Pixel defects (maximum counts, allowed defect types, and locations), Artifacts (Limited), Temporal response, Luminance (maximum, minimum, achievable, and recommended), Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF), Color tracking (primary colors and color gamut).
Electrical safety and EMC testing were conducted. The devices comply with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject device does not require animal or clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K183498, K202374, K163335

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

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

1

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 (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 Ouality Center for Devices and Radiological Health

Enclosure

2

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)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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information unless it displays a currently valid OMB number."

3

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:luzhonghao@hisense.com
	Tel: +86-532-83091111
	Fax:+86-532-83091111
	Secondary Contact Person
	Wu yalan
	RA Manager
	Qingdao Hisense Medical Equipment Co. Ltd.
	Mail: wuyalan@hisense.com
	Tel: +86-532-83091111
	Fax:+86-532-83091111
Device Trade Name:	Hisense LCD monitor HMD2C21A, HMD4C27S,
HMD6C30D
Common/Usual Name:	2M/4M/6M Color LCD monitor
Classification Name:	Display, Diagnostic Radiology 21CFR 892.2050
Product Code:	PGY
	N
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

4

| Device Description: | The Hisense LCD monitors are intended for
trained medical practitioners and provides the
image viewing and medical diagnostic functions.
HMD2C21A, HMD4C27S, HMD6C30D are
developed with different resolution:1600 x 1200,
2560 x 1440, 3280 × 2080. So the LCD monitors
can be used in different environment according to
different resolution requirement.
The three models also developed with same
features such as energy saving, ambient light
induction, front-facing sensor calibration, etc. In
particular, HMD4C27S, HMD6C30D have
body-inductive energy-saving and auto awake
function.
The Hisense LCD monitor complies with
standards as following:

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
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. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Technology: | 1)HMD2C21A is a 2M color LCD diagnostic
monitor. It strictly complies with the DICOM
standard and has the features of high-resolution,
high-brightness display. It uses OSD menu
software, monitor control software, and quality
control software to achieve functional stability.

HMD4S27S is a 4M color, one-screen and
dual-display diagnostic monitor. It strictly complies
|
| Determination of Substantial
Equivalence: | with the DICOM standard and integrates the
functions of image browsing, reading and writing
clinical reports, etc. It uses OSD menu software,
monitor control software, and quality control
software to achieve functional stability.
3)HMD6C30D is a 6M color, one-screen and
dual-display diagnostic monitor. The built-in
DICOM standard LUT ensures the long-term
stability and consistency of the display, and truly
restores the original information of the image. It
uses OSD menu software, monitor control
software, and quality control software to achieve
functional stability. |
| | Summary of Non-Clinical Tests:
The Hisense LCD monitor (HMD2C21A,
HMD4C27S, HMD6C30D) complies with
standards as following:

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
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 Hisense LCD monitor HMD2C21A,
HMD4C27S, HMD6C30D are substantially
equivalent to JUSHA-C270G, C44W+, RadiForce
RX660. They have equivalent characteristics and
functions according to comparison table, please
refer to 2. Product Comparison
The following quality assurance measures were
applied to the development of the system:
·Electrical Safety & EMC test
·Performance test |
| | Risk Management & Analysis Design Reviews Raw materials verification Final acceptance test etc. Summary of Clinical Tests:
The subject of this premarket submission,
Hisense LCD monitor, don't 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. |
| Conclusion | Qingdao Hisense Medical Equipment Co., Ltd.
Considers the Hisense HMD2C21A, HMD4C27S
and HMD6C30D LCD monitor to be as safe, as
effective, and performance is substantially
equivalent to the predicate devices. |

5

6

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

7

| ID | Elements of
Comparison | Proposed device | Predicate Device |
|---------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Number | K222208 | K183498 |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd |
| | Device
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
Brightness(typ) | 1000 cd/m² | 1000cd/m² |
| 1.11 | Recommended
brightness | 400cd/m² | 350cd/m² |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambient
light
sensing | Built-in ambient light sensor | Ambient luminance
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
calibration | Front-facing sensor
Upper Computer Software | Built in calibration sensor
provided |
| 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 |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 |
| 2.3 | Video bandwidth | DVI: 215MHz
DisplayPort : 215MHz | DVI: 215MHz
DisplayPort : 215MHz |
| 3.Power Related Specification | | | |
| 3.1 | Power
Requirements | 24 V DC, 1.9A | DC 24V |
| 3.2 | Power
Consumption/
save mode | 45.6W/Below 1W | 50W/less than 0.5W |
| 3.3 | Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM
DisplayPort 1.1a |
| 4.Miscellaneous Features/Specifications | | | |
| ID | Elements of
Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K183498 |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | Nanjing Jusha Display
Technology Co., Ltd |
| | Device
type/model | HMD2C21A | JUSHA-C270G |
| 4.1 | USB ports | 1 uplink port and
2 downlink ports/ Rev. 2.0 | 1 upstream (endpoint),
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
e: | Built-in embedded software | Built-in embedded software |
| 4.5 | Dimensions w/o
stand
(W x H x D) | Without base:384 mm x 492
mm x 70mm
With base:384 mm x
517.5-637.5 mm x 273.5 mm | Without stand: 382mm
x490mm x77mm
With stand: 382mm x635mm
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
used in displaying radiological
images for review, analysis and
diagnosis by trained
medical practitioners.

The product does not support
the display of mammography
images for diagnosis. | JUSHA-C270G 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.

8

9

2.2 HMD4C27S and its predicate

Tabel2 HMD4C27S Detailed Comparison with Predicate

10

11

510(k) Premarket Notification Submission

3.2 HMD6C30D and its predicate

Tabel3 HMD6C30D Detailed Comparison with Predicate

| ID | Elements of
Comparison | Proposed device | Predicate Device |
|-----------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Number | K222208 | K163335 |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | EIZO Corporation |
| | Device
type/model | HMD6C30D | RadiForce RX660 |
| | 1.Display Performance/Specifications | | |
| 1.1 | Screen size | 30 inches | 30" |
| 1.2 | Screen
Technology | Color LCD panel (IPS) | IPS |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°
(CR ≥ 10) | H: 176°, V: 176° |
| 1.4 | Pixel array | 3280 × 2080 | 6MP (3,280 x 2,048) |
| 1.5 | Display Area | 645.504 (H) × 409.344 (V)
(mm) | 645.5 mm x 403.0 mm |
| 1.6 | Pixel Pitch | 0.197 (H) x 0.197 (V) (mm) | 0.1968 mm x 0.1968 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 2000:1 (typ.) | 1500:1 |
| 1.9 | Frame rate | 48-62Hz | 31 - 127 kHz / 22 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode:
29.5 - 30.5 Hz, 59 - 61 Hz |
| 1.10 | Maximum
Brightness(typ) | 1300cd/m² | 1000 cd/m² |
| 1.11 | Recommended | 400 cd/m² | 500 cd/m² |
| | Elements of
Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K163335 |
| ID | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | EIZO Corporation |
| | Device
type/model | HMD6C30D | RadiForce RX660 |
| | brightness | | |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambient
light
sensing | Built-in ambient light sensor | Yes |
| 1.14 | Response Time | 30 ms (typ.) | 25ms |
| 1.15 | Aspect Ratio | 16:10 | 16:10 |
| 1.16 | Luminance
non-uniformity
compensation | NA | Digital Uniformity Equalizer |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| 2.Video Signals | | | |
| 2.1 | Video
Input
Signal | DVI-D x 2,
DisplayPort x 2,
HDMI x 1 | DVI-D (dual link) x 1,
DisplayPort x 2 |
| 2.2 | Output Signal | DisplayPort connector | DisplayPort x 1 (daisy chain |
| 2.3 | Video bandwidth | DVI: 215MHz
DisplayPort : 215MHz | DVI: 215MHz
DisplayPort : 215MHz |
| 3.Power Related Specification | | | |
| 3.1 | Power
Requirements | 24 V DC, 6.25 A | AC 100 - 240 V: 50 / 60 Hz |
| 3.2 | Power
Consumption/
save mode | 150W/Below 0.5W | 190 W / Less than 1.6 W |
| 3.3 | Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a |
| 4.Miscellaneous Features/Specifications | | | |
| 4.1 | USB ports | 1 uplink port and
2 downlink ports/ Rev. 2.0 | 2 upstream,
3 downstream / Rev. 2.0 |
| 4.2 | Display color | 10bit | 10-bit |
| 4.3 | Software/Firmware | Built-in embedded software | Built-in embedded software |
| ID | Elements of
Comparison | Proposed device | Predicate Device |
| | 510(k) Number | K222208 | K163335 |
| | Manufacturer | Qingdao Hisense Medical
Equipment Co., Ltd | EIZO Corporation |
| | Device
type/model | HMD6C30D | RadiForce RX660 |
| | 4.4 | Dimensions w/o
stand
(W x H x D) | Without base:700 mm x
478mm x 68mm
With base:700 mm x 516-626
mm x 274 mm |
| 4.5 | Net weight | 17.1 kg (excluding the base) | 10.1kg(without stand) |
| 4.6 | VESA standard | 100 x 100 (mm) | 100 x 100 (mm) |
| 5. Intended use | | | |
| 5.1 | Indication for use | This product is intended to be
used in displaying radiological
images for review, analysis
and diagnosis by trained
medical practitioners.
The
product does not support the
display of mammography
images for diagnosis. | The display is intended to be
used for displaying
and
viewing digital images
(excluding digital
mammography) for review
and analysis by trained
medical practitioners. |
| 6 Applicable standard | | | |
| 6.1 | Applicable
standard | Compliance with IEC 60601-1
Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1
Compliance with IEC 60601-1-2 |

12

13

510(k) Premarket Notification Submission

3.Performance data

The following performance data were provided in support of the substantial equivalence determination.

3.1Bench testing:

The bench tests were performed on the proposed devices HMD2C21A, HMD4C27S, HMD6C30D in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline). Bench testing was conducted to demonstrate the HMD2C21A, HMD4C27S, HMD6C30D meets all performance standards as follows:

14

510(k) Premarket Notification Submission

Table4 Bench test
Measurements Guidance	Recommended for
Non-mammography
Display Submissions	HMD2C21A,
HMD4C27S,HMD6C30D
Measurements
a. Spatial resolution	Yes	Measure Spatial resolution
with TG18 Resolution
b. Pixel defects (maximum
counts, allowed defect types,
and locations)	Yes	Measure Pixel defects with
TG18
c. Artifacts	Yes (Limited)	Measure Artifacts with
TG18
d. Temporal response	Yes	Measure Temporal
response with TG18
e. Luminance (maximum,
minimum, achievable, and
recommended)	Yes	Measure Luminance with
TG18
f. Conformance to a
grayscale-to-luminance
function (e.g., DICOM GSDF)	Yes	Measure Conformance to a
grayscale-to-luminance
function with TG18
g. Luminance at 30° and 45° in
diagonal, horizontal, and
vertical directions at center and
four corners	No	-
h. Luminance uniformity or
Mura test	No	-
i. Stability of luminance and
chromaticity response with
temperature and time of
operation or on-time	No	-
j. Spatial noise	No	-
k. Reflection coefficient	No	-
I. Veiling glare or small-spot
contrast	No	-
m. Color tracking (primary
colors and color gamut)	Yes	Measure Color tracking
with TG18
n. Gray tracking (gray shades
and white point)	No	-

3.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the HMD2C21A, HMD4C27S, HMD6C30D. The devices comply with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

3.3Animal and clinical study

The subject of this premarket submission, Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D do not require animal or clinical studies to support substantial equivalence.

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4. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Qingdao Hisense Medical Equipment Co., Ltd. concludes that:

O The intended uses of proposed devices (HMD2C21A, HMD4C27S, HMD6 C30D) are equivalent to the predicate devices.
The technological characteristics differences between proposed devices ● (HMD2C21A, HMD4C27S, HMD6C30D) and the predicate devices do not affect the safety and effectiveness, so no new risk is raised.
. Demonstrated by the bench tests, the display characteristics of proposed devices (HMD2C21A, HMD4C27S, HMD6C30D) are equivalent to those of the predicate devices.