LCD Monitor (MD310C, MD310G, MD210G)

• K Number: K170944
• Device Name: LCD Monitor (MD310C, MD310G, MD210G)
• Manufacturer: BenQ Corporation
• Date Cleared: 2017-05-25 ( 56 days)
• Product Code: PGY
• Regulation Number: 892.2050

Intended Use

BenQ LCD monitor (MD310C, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Description

BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).

Predicate Devices

K153354, K150821, K143076

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a medical display monitor and does not mention any AI or ML capabilities. The performance studies focus on display characteristics and safety, not algorithmic performance.

Therapeutic

No.
The document states that the device is an LCD monitor intended for displaying and viewing digital images for review, analysis, and diagnosis, but it does not perform any therapeutic function.

Diagnostic

Yes
The device is used for displaying and viewing digital images for review, analysis, and diagnosis by trained medical practitioners, which is a core function of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is explicitly described as an LCD monitor, which is a hardware component used for displaying images. The description details physical characteristics like screen size and resolution.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
• This device is a medical monitor used for displaying and viewing digital images. It's a display device for medical images, not a device that analyzes biological samples.

The description clearly states its purpose is for "displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners." This aligns with the function of a medical image display device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BenQ LCD monitor (MD310G, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review. analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

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

PGY

Device Description

BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital images

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)

A series of safety and performance tests were conducted on the subject device, LCD Monitor (MD310C, MD310G, MD210G).

• Reliability test
• Software Validation
• . Electromagnetic compatibility and electrical safety
• . Function test
• . Usability test
  All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.

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.

K153354, K150821, K143076

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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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BenO Corporation % Mr. Calvin KT Chang Project Manager 16 Jihu Road. Neihu Taipei. 114 Taiwan REPUBLIC OF CHINA

May 25, 2017

Re: K170944

Trade/Device Name: LCD Monitor (MD310C, MD310G, MD210G) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 10, 2017 Received: March 30, 2017

Dear Mr. Chang:

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. 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 (reporting of medical

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Robert Oals

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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)

K170944

Device Name

LCD Monitor (MD310C, MD310G, MD210G)

Indications for Use (Describe)

BenQ LCD monitor (MD310G, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review. analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Traditional 510(k) Section 5 - 510 (k) Summary

510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	March 10, 2017
5.3	Submitter:	BenQ Corporation
	Address:	16 Jihu Road, Neihu, Taipei 114, Taiwan
		(R.O.C.)
	Phone:	[phone]
	Fax:	[phone]
	Contact:	Calvin KT Chang
		([e-mail])

Identification of the Device: 5.4

Proprietary/Trade name:	LCD Monitor
Model Number:	MD310C, MD310G, MD210G
Regulation Description:	Picture archiving and communications
system
Review Panel:	Radiology
Regulation Number:	892.2050
Device Class:	II
Product Code:	PGY

5.5 Identification of the Predicate Devices:

Predicate Device Name:	3MP Color LCD Monitor, RadiForce RX350
Manufacturer:	EIZO Corporation
Regulation number:	892.2050
Device Class:	II
Product Code:	PGY
510(k) Number:	K153354

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Traditional 510(k) Section 5 - 510 (k) Summary

Predicate Device Name:	Nio 3MP LED (MDNG-3220)
Manufacturer:	Barco N.V.
Regulation number:	892.2050
Device Class:	II
Product Code:	PGY
510(k) Number:	K150821
Predicate Device Name:	20.1 inch (51 cm) Monochrome LCD
Monitor ME205 (ML20205)
Manufacturer:	JVC KENWOOD CORPORATION
Regulation number:	892.2050
Device Class:	II
Product Code:	PGY
510(k) Number:	K143076

5.6 Intended Use/ Indications for Use of the Device

BenQ LCD monitor (MD310C, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

5.7 Device Description

BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).

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5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, LCD Monitor (MD310C, MD310G, MD210G).

• Reliability test
• Software Validation
• . Electromagnetic compatibility and electrical safety
• . Function test
• . Usability test

All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.

5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

5.10 Substantial Equivalence Determination

The LCD Monitor (MD310C, MD310G, MD210G) has the same intended use, principle of operation and technological characteristics with the 3MP Color LCD Monitor, RadiForce RX350 (K153354), Nio 3MP LED (MDNG-3220) (K150821) and 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) (K143076). A series of tests were performed and demonstrated substantial equivalence between the subject and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|---------------------|----------------|-----------------------|---------------------------------------------|
| Proprietary
name | LCD monitor | 3MP Color LCD Monitor | NA |

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Model	MD310C	RadiForce RX350	NA
510(k) No.		K153354	NA
Intended use	BenQ LCD monitor
(MD310C, MD310G and
MD210G) is intended to be
used in displaying and
viewing digital images for
review, analysis and
diagnosis by trained
medical practitioners. It
does not support the display
of mammography images
for diagnosis.	This product is intended to
be used in displaying and
viewing digital images for
review, analysis and
diagnosis by trained
medical practitioners. It
does not support the
display of mammography
images for diagnosis.	The subject
device has the
same intended use
as the predicate
device.
	LCD panel
Technology	TFT color LCD panel
(IPS)	Color (IPS)	Same
Backlight	LED	LED	Same
Panel size
(diagonal)	21.3" (54.1 cm)	21.3" (54.1 cm)	Same
Display size
(H x V)	433.1 x 324.8 mm	433.2 mm x 324.9 mm	Slightly different
but does not
adversely impact
safety and
effectiveness of
subject device
Mega pixels	3 megapixel	3 megapixel	Same
Native
resolutions (H
x V)	2048 x 1536	2048 x 1536	Same
Pixel pitch (H
x V)	0.2115 x 0.2115 mm	0.2115 mm x 0.2115 mm	Same
Viewing
angle (H, V)	176°/176°	178°/ 178°	Different but does
not adversely
impact safety and
effectiveness of
subject device
Response
time	40 ms (Typ.)	25 ms (Typ.)	Different but does
not adversely
impact safety and
effectiveness of
subject device
Brightness	800 cd/m² (Typ.)	1,000 cd/m² (Typ.)	Different but does
not adversely
impact safety and
effectiveness of
subject device
Contrast ratio	1400:1 (Typ.)	1500 : 1 (Typ.)	Different but does
not adversely
impact safety and
effectiveness of
subject device
Aspect ratio	4 : 3	4 : 3	Same
Display colors	1.07 billion colors
(maximum)	1.07 billion colors
(maximum)	Same
Luminance
non-uniformity
compensation	Digital Uniformity
Equalizer	Digital Uniformity
Equalizer	Same
Connectivity
Input
terminals	DVI-D (Dual Link)
DisplayPort	DVI-D (dual link)
DisplayPort	Same
USB
ports/standard	1 upstream,
2 downstream
/ Rev. 2.0	1 upstream,
2 downstream
/ Rev. 2.0	Same
Scanning
frequency (H,
V)			Different but
		31-127 kHz / 29-61.5 Hz	does not
	V: 50~76Hz, H:	(VGA Text: 69 - 71 Hz)	adversely impact
	30KHz~80KHz	Frame synchronous mode:	safety and
		29.5 - 30.5 Hz, 59 - 61 Hz	effectiveness of
			subject device
		Power supply
	AC 100-240V,	AC 100-240V,	Same
Power input	50~60 Hz	50 / 60 Hz
			Different but does
			not adversely
Power	95 W (Maximum)	89 W / Less than 1 W	impact safety and
consumption			effectiveness of
			subject device
			Different but does
	DVI DMPM, DisplayPort
1.1a	DVI DMPM,
DisplayPort 1.2a	not adversely
Power			impact safety and
management			effectiveness of
			subject device
		Physical
	Portrait:
369 x 490.4 x 94.4 mm
Landscape:
490.4 x 369 x 94.4 mm	354 x 462 x 78 mm	Different but
Dimensions			does not
w/o stand			adversely impact
(W x H x D)			safety and
			effectiveness of
			subject device
Mounting	100 x 100 mm VESA	100 x 100 mm VESA	Same
	compliant	compliant
Miscellaneous Features/Specifications
QC software	N/A	RadiCS	BenQ LCD
			Monitor is
			calibrated in
			factory before
shipment
Sensors	Backlight Sensor,
Eco(Presence) Sensor,
Front Sensor,
Ambient Light Sensor	Backlight Sensor,
Presence Sensor,
Integrated Front Sensor,
Ambient Light Sensor	Same

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Section 5 - Traditional 510(k)

Section 5 - 510 (k) Summary

---

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| Item | Subject device | Predicate device | Substantial
equivalence
determination | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--|
| Proprietary
name | LCD monitor | Nio 3MP LED | NA | |
| Model | MD310G | MDNG-3220 | NA | |
| 510(k) No. | | K150821 | NA | |
| Intended use | BenQ LCD monitor
(MD310C, MD310G and
MD210G) is intended to be
used in displaying and
viewing digital images for
review, analysis and
diagnosis by trained
medical practitioners. It
does not support the display
of mammography images
for diagnosis. | The Nio 3MP LED
(MDNG-3220) Medical
Flat Panel Display System
is intended to be used as a
tool in displaying and
viewing digital images
(excluding digital
mammography) for review
and analysis by trained
medical practitioners. | The subject
device has the
same intended use
as the predicate
device. | |
| LCD panel | | | | |
| Technology | TFT monochrome LCD
panel (IPS) | TFT AM LCD Dual
Domain IPS | Same | |
| Backlight | LED | LED | Same | |
| Panel size
(diagonal) | 21.3" (54.1 cm) | 20.8" (52.0 cm) | Different but does
not adversely | |
| | | | impact safety and
effectiveness of
subject device | |
| Display size
(H x V) | 433.1 x 324.8 mm | 424 mm x 318 mm | Different but does
not adversely
impact safety and
effectiveness of
subject device | |
| Mega pixels | 3 megapixel | 3 megapixel | Same | |
| Native
resolutions (H x V) | 2048 x 1536 | 2048 x 1536 | Same | |
| Pixel pitch (H x V) | 0.2115 x 0.2115 mm | 0.207 mm x 0.207 mm | Different but does
not adversely
impact safety and
effectiveness of
subject device | |
| Viewing
angle (H, V) | 176°/176° | 176°/176° | Same | |
| Response
time | 40 ms (Typ.) | 30 ms (typical) | Different but does
not adversely
impact safety and
effectiveness of
subject device | |
| Brightness | 1700 cd/m² (Typ.) | 1200 cd/m² typical | Different but does
not adversely
impact safety and
effectiveness of
subject device | |
| Contrast ratio
(typical) | 1400:1 | 1200:1 | Different but does
not adversely
impact safety and
effectiveness of
subject device | |
| | | | effectiveness of | |
| | | | subject device | |
| Aspect ratio
(H:V) | 4 :3 | 4:3 | Same | |
| Color imaging | No | No | Same | |
| Gray imaging | Yes | Yes | Same | |
| | | Connectivity | | |
| Input | DVI-D (Dual Link) | DVI-D Dual Link | | |
| terminals | DisplayPort | DisplayPort | Same | |
| USB | 1 upstream, | 1 upstream, | | |
| ports/standard | 2 downstream | 2 downstream | Same | |
| | / Rev. 2.0 | / Rev. 2.0 | | |
| | | | Different but | |
| Scanning | V: 5076Hz, H:
30KHz80KHz | 15-129 kHz; 25-98 Hz | does not | |
| frequency (H, | | | adversely impact | |
| V) | | | safety and | |
| | | | effectiveness of | |
| | | | subject device | |
| | | Power supply | | |
| Power input | AC 100-240V, | AC 100-240V, | Same | |
| | 50~60 Hz | | | |
| | 80 W (Maximum) | 50 W (nominal) | Different but does | |
| Power | | | not adversely | |
| consumption | | | impact safety and | |
| | | | effectiveness of | |
| | | | subject device | |
| Physical | | | | |
| Dimensions
w/o stand
(W x H x D) | Portrait: | 378 x 491 x 84 mm | Different but | |
| | 369 x 490.4 x 94.4 mm | | does not | |
| | Landscape: | | adversely impact | |
| | 490.4 x 369 x 94.4 mm | | safety and | |
| | | | effectiveness of | |
| | | | subject device | |
| Mounting | 100 x 100 mm VESA
compliant | 100 x 100 mm VESA
compliant | Same | |

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11

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| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Proprietary
name | LCD monitor | 20.1 inch (51 cm)
Monochrome LCD Monitor
ME205 | NA |
| Model | MD210G | ML20205 | NA |
| 510(k) No. | – | K143076 | NA |
| Intended use | BenQ LCD monitor
(MD310C, MD310G and
MD210G) is intended to be
used in displaying and
viewing digital images for
review, analysis and
diagnosis by trained
medical practitioners. It
does not support the display
of mammography images
for diagnosis. | 20.1 inch (51 cm)
Monochrome 2M pixel
LCD Monitor ME205
(ML20205) is intended to
be used in displaying and
viewing medical images
for diagnosis by trained
Medical practitioners. It is
not meant to be used in
digital mammography. | The subject
device has the
same intended use
as the predicate
device. |
| LCD panel | | | |
| Technology | TFT Monochrome LCD
Panel | Monochrome TFT | Same |
| Backlight | LED | LED | Same |
| Panel size
(diagonal) | 20.1" (51.1 cm) | 20.1" | Same |
| Display size | 408 x 306 mm | 408 x 306 mm | Same |
| (H x V) | | | |
| Mega pixels | 2 megapixel | 2 megapixel | Same |
| Native
resolutions (H
x V) | 1600 x 1200 | 1600 x 1200 | Same |
| Pixel pitch (H
x V) | 0.255 x 0.255 mm | 0.255 x 0.255 mm | Same |
| Viewing
angle (H, V) | 170°/170° | 170°/170° | Same |
| Brightness | 1000 cd/m² (Typ.) | 1000 cd/m² typ. | Same |
| Contrast ratio | 1400:1 (Typ.) | 1000:1 (Typ.) | Different but does
not adversely
impact safety and
effectiveness of
subject device |
| Connectivity | | | |
| Input
terminals | VGA
DVI-D
DisplayPort | DVI-I 29-pin connector
DisplayPort connector | Different but does
not adversely
impact safety and
effectiveness of
subject device |
| USB
ports/standard | 1 upstream,
2 downstream
/ Rev. 2.0 | 1 upstream,
2 downstream
/ Rev. 2.0 | Same |
| Scanning
frequency (H,
V) | Digital: 31.47 – 80 kHz, 60
Hz, Analog: 31.47 - 80 kHz,
55 - 76 Hz | Horizontal: 30 - 75 kHz,
Vertical: 55 - 60 Hz | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| Power supply | | | |
| Power input | AC 100-240V, 5060 Hz | AC 100-240V, 5060 Hz | Same |
| Power consumption | 55 W (Maximum) | 38W
Power management feature | Different but does not adversely
impact safety and
effectiveness of
subject device |
| Physical | | | |
| Dimensions
w/o stand
(W x H x D) | Portrait:
369 x 490.4 x 94.4 mm
Landscape:
490.4 x 369 x 94.4 mm | Portrait:
353 x 512 – 573 x 220 mm
Landscape:
453 x 462 – 523 x 220 mm | Different but
does not
adversely impact
safety and
effectiveness of
subject device |
| | Mounting | 100 x 100 mm VESA
compliant | 100 x 100 mm VESA
compliant |

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Traditional 510(k) Section 5 - 510 (k) Summary

5.11 Similarity and Difference

The LCD Monitor, model MD310C, MD310G and MD210G has been compared with "3MP Color LCD Monitor, RadiForce RX350," "Nio 3MP LED (MDNG-3220)" and "20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205") respectively. The subject device has the same intended use, principle of operation and technological characteristics as these predicate devices. Although there are several specification that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problems of substantial equivalence. The subject device is substantially equivalent to the predicate devices in intended use, safety and performance claims.

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Traditional 510(k) Section 5 - 510 (k) Summary

5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that LCD Monitor (MD310C, MD310G, MD210G) is substantially equivalent to the predicate devices.