LCD Monitor (MD310C, MD310G, MD210G)

K170944 · Benq Corporation · PGY · May 25, 2017 · Radiology

Device Facts

• Record ID: K170944
• Device Name: LCD Monitor (MD310C, MD310G, MD210G)
• Applicant: Benq Corporation
• Product Code: PGY · Radiology
• Decision Date: May 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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 Story

LCD monitors (MD310C, MD310G, MD210G) for medical image display; inputs digital image data via DVI-D or DisplayPort; transforms data into visual output on TFT LCD panels (color or monochrome) with LED backlighting; used by trained medical practitioners in clinical settings for review, analysis, and diagnosis; excludes mammography; provides high-resolution visualization to assist clinicians in diagnostic decision-making; includes integrated sensors (backlight, presence, front, ambient light) and digital uniformity equalization to maintain image quality.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including reliability, software validation, electromagnetic compatibility, electrical safety, functional testing, and usability testing.

Technological Characteristics

TFT LCD panels (IPS); LED backlight; 2MP or 3MP resolution; DVI-D/DisplayPort connectivity; USB 2.0 ports; VESA 100x100mm mounting; digital uniformity equalizer; integrated sensors (backlight, presence, front, ambient light); factory calibrated.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images for review, analysis, and diagnosis. Excludes mammography images.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• 3MP Color LCD Monitor, RadiForce RX350 (K153354)
• Nio 3MP LED (MDNG-3220) (K150821)
• 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) (K143076)

Submission Summary (Full Text)

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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)

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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<br>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<br>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<br>equivalence<br>determination |
|---------------------|----------------|-----------------------|---------------------------------------------|
| Proprietary<br>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<br>(MD310C, MD310G and<br>MD210G) is intended to be<br>used in displaying and<br>viewing digital images for<br>review, analysis and<br>diagnosis by trained<br>medical practitioners. It<br>does not support the display<br>of mammography images<br>for diagnosis. | This product is intended to<br>be used in displaying and<br>viewing digital images for<br>review, analysis and<br>diagnosis by trained<br>medical practitioners. It<br>does not support the<br>display of mammography<br>images for diagnosis. | The subject<br>device has the<br>same intended use<br>as the predicate<br>device. |
| | LCD panel | | |
| Technology | TFT color LCD panel<br>(IPS) | Color (IPS) | Same |
| Backlight | LED | LED | Same |
| Panel size<br>(diagonal) | 21.3" (54.1 cm) | 21.3" (54.1 cm) | Same |
| Display size<br>(H x V) | 433.1 x 324.8 mm | 433.2 mm x 324.9 mm | Slightly different<br>but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device |
| Mega pixels | 3 megapixel | 3 megapixel | Same |
| Native<br>resolutions (H<br>x V) | 2048 x 1536 | 2048 x 1536 | Same |
| Pixel pitch (H<br>x V) | 0.2115 x 0.2115 mm | 0.2115 mm x 0.2115 mm | Same |
| Viewing<br>angle (H, V) | 176°/176° | 178°/ 178° | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device |
| Response<br>time | 40 ms (Typ.) | 25 ms (Typ.) | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device |
| Brightness | 800 cd/m² (Typ.) | 1,000 cd/m² (Typ.) | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device |
| Contrast ratio | 1400:1 (Typ.) | 1500 : 1 (Typ.) | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device |
| Aspect ratio | 4 : 3 | 4 : 3 | Same |
| Display colors | 1.07 billion colors<br>(maximum) | 1.07 billion colors<br>(maximum) | Same |
| Luminance<br>non-uniformity<br>compensation | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | Same |
| Connectivity | | | |
| Input<br>terminals | DVI-D (Dual Link)<br>DisplayPort | DVI-D (dual link)<br>DisplayPort | Same |
| USB<br>ports/standard | 1 upstream,<br>2 downstream<br>/ Rev. 2.0 | 1 upstream,<br>2 downstream<br>/ Rev. 2.0 | Same |
| | | | |
| Scanning<br>frequency (H,<br>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<br>1.1a | DVI DMPM,<br>DisplayPort 1.2a | not adversely |
| Power | | | impact safety and |
| management | | | effectiveness of |
| | | | subject device |
| | | Physical | |
| | Portrait:<br>369 x 490.4 x 94.4 mm<br>Landscape:<br>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<br>shipment |
| Sensors | Backlight Sensor,<br>Eco(Presence) Sensor,<br>Front Sensor,<br>Ambient Light Sensor | Backlight Sensor,<br>Presence Sensor,<br>Integrated Front Sensor,<br>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<br>equivalence<br>determination | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--|
| Proprietary<br>name | LCD monitor | Nio 3MP LED | NA | |
| Model | MD310G | MDNG-3220 | NA | |
| 510(k) No. | | K150821 | NA | |
| Intended use | BenQ LCD monitor<br>(MD310C, MD310G and<br>MD210G) is intended to be<br>used in displaying and<br>viewing digital images for<br>review, analysis and<br>diagnosis by trained<br>medical practitioners. It<br>does not support the display<br>of mammography images<br>for diagnosis. | The Nio 3MP LED<br>(MDNG-3220) Medical<br>Flat Panel Display System<br>is intended to be used as a<br>tool in displaying and<br>viewing digital images<br>(excluding digital<br>mammography) for review<br>and analysis by trained<br>medical practitioners. | The subject<br>device has the<br>same intended use<br>as the predicate<br>device. | |
| LCD panel | | | | |
| Technology | TFT monochrome LCD<br>panel (IPS) | TFT AM LCD Dual<br>Domain IPS | Same | |
| Backlight | LED | LED | Same | |
| Panel size<br>(diagonal) | 21.3" (54.1 cm) | 20.8" (52.0 cm) | Different but does<br>not adversely | |
| | | | impact safety and<br>effectiveness of<br>subject device | |
| Display size<br>(H x V) | 433.1 x 324.8 mm | 424 mm x 318 mm | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Mega pixels | 3 megapixel | 3 megapixel | Same | |
| Native<br>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<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Viewing<br>angle (H, V) | 176°/176° | 176°/176° | Same | |
| Response<br>time | 40 ms (Typ.) | 30 ms (typical) | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Brightness | 1700 cd/m² (Typ.) | 1200 cd/m² typical | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Contrast ratio<br>(typical) | 1400:1 | 1200:1 | Different but does<br>not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| | | | effectiveness of | |
| | | | subject device | |
| Aspect ratio<br>(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: 50~76Hz, H:<br>30KHz~80KHz | 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 | |
| |…