8MP Color LCD Monitor (C81W+)

K162527 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Sep 30, 2016 · Radiology

Device Facts

• Record ID: K162527
• Device Name: 8MP Color LCD Monitor (C81W+)
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Sep 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Story

The 8MP Color LCD Monitor (C81W+) is a 31.1-inch TFT color LCD diagnostic display. It receives digital video signals (DVI-D, DisplayPort) from medical imaging systems. The device features an LED backlight, 4096x2160 resolution, and integrated sensors (backlight, front, ambient light) to maintain stable brightness and calibration. It is used by trained medical practitioners in clinical settings to view high-resolution medical images, including breast tomosynthesis, digital mammography, ultrasound, and general radiography. The monitor includes an anti-glare screen to improve image clarity under various lighting conditions. By providing a calibrated, high-resolution display, the device assists clinicians in the review, analysis, and diagnosis of medical images, potentially improving diagnostic accuracy and patient outcomes.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence was demonstrated through bench testing, including conformance to DICOM GSDF, luminance stability, chromaticity, reflection, contrast ratio, MTF, noise power spectrum, and temporal response measurements in accordance with AAPM TG18 guidelines.

Technological Characteristics

31.1-inch TFT color LCD (IPS) panel; 4096x2160 resolution; LED backlight; 850 cd/m² max luminance; 1450:1 contrast ratio; 178° viewing angle; DVI-D and DisplayPort inputs; integrated backlight, front, and ambient light sensors; DC 24V/9A power; VESA DDC 2B plug-and-play; digital uniformity equalizer.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including standard and multi-frame digital mammography and breast tomosynthesis, for review, analysis, and diagnosis.

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

• EIZO Corporation, 8MP Color LCD Monitor, RadiForce RX850, RX850-AR (K152713)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.

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

Shenzhen Beacon Display Technology Co., Ltd. % Miss Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA

October 6, 2016

Re: K162527 Trade/Device Name: 8MP Color LCD Monitor (C81W+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 1, 2016 Received: September 9, 2016

Dear Miss Ailing:

This letter corrects our substantially equivalent letter of September 30, 2016.

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21CFR 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,

Jeff Rodriquez

for 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

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

510(k) Number (if known)

Device Name

8MP Color LCD Monitor (C81W+)

Indications for Use (Describe)

The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 008_510 (k) Summary

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## 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Date Prepared [21 CFR807.92 (a) (1)]

July 6, 2016

## 2. Submitter's Information [21 CFR807.92 (a) (1)]

| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|------------------|---------------------------------------------------------------------------------------------------|
| Address: | 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road, Nanshan<br>District, Shenzhen, 518055 China |
| Contact Name: | Fu Ailing |
| Telephone No.: | [phone]-5150 |
| Fax No.: | [phone] |
| Email Address: | [e-mail] |

#### 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

| Trade Name/Model: | 8MP Color LCD Monitor (C81W+) |
|-----------------------|-------------------------------|
| Common Name: | 8MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product code: | PGY |
| Classification Panel: | Radiology |
| Device Class: | II |

## 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

The identified predicates within this submission are as follows:

EIZO Corporation, 8MP Color LCD Monitor, RadiForce RX850, RX850-AR has been cleared by FDA through 510(k) No. K152713 (Decision Date - November 20, 2015).

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### 5. Description of the Device [21 CFR 807.92(a) (4)]

The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

#### 6. Intended Use [21 CFR 807.92(a)(5)]

The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

| Panel | 31", TFT, color, LCD screen, anti-glare, hard coating |
|-----------------------------|-------------------------------------------------------|
| Brightness (Max.) | 850 cd/m² |
| CR (Typ.) | 1450:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0.1704 × (V) 0.1704 mm |
| Native resolution | 4,096 x 2,160 |
| Display area | 697.9mm(H)x368.0mm (V) |
| Compatible video<br>signals | 4096 x 2160@60Hz; DP/DVI |
| Horizontal resolution | 4096 |
| Aspect ratio | 17:9 |
| Screen size | 31.1" real diagonal |
| Power | DC 24V/9A |

#### 7. Technological Characteristics [21 CFR 807.92(a)(6)]

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| Power consumption | Max. 180 W |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (dual link) * 2 |
| Plug and play | VESA DDC 2B |
| Dimension | 755 mm (W) x 600.6 mm (H) x 251.4mm (D) (with stand) 755 mm (W) x 433.8 mm (H) x 99.1 mm (D) (without stand) |
| Weight | 13 kg (without Stand) 17.5 kg (with Stand) |
| Operating temperature and humidity | Temperature: 0°C ~ 40°C Humidity: 20% ~80% |
| Storage temperature and humidity | Temperature: -20°C ~ 60°C Humidity:10% ~90% |

## 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

#### 8.1 Intended uses:

#### Table 1 Intended Use Comparison

| ID | Comparison Item | Proposed Device<br>8MP Color LCD Monitor<br>(C81W+) | Predicate Device<br>8MP Color LCD Monitor<br>(RX850, RX850-AR) | |
|------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 1 | Intended Use | The 8MP Color LCD Monitor<br>(C81W+) is intended to be<br>used in displaying and viewing<br>digital images, including<br>standard and multi-frame<br>digital mammography, for<br>review, analysis and diagnosis<br>by trained medical<br>practitioners. It is specially<br>designed for breast<br>tomosynthesis applications. | "8MP Color LCD Monitor<br>(RX850, RX850-AR)" is intended<br>to be used in displaying and<br>viewing digital images, including<br>standard and multi-frame digital<br>mammography, for review,<br>analysis and diagnosis by trained<br>medical practitioners. It is<br>specially designed for breast<br>tomosynthesis application. | |
| ID | Comparison Item | Proposed Device<br>8MP Color LCD<br>Monitor (C81W+) | Predicate Device<br>8MP Color LCD<br>Monitor<br>(RX850, RX850-AR) | Explanation of<br>Difference |
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen<br>Technology | TFT Color LCD Panel<br>(IPS) | TFT Color LCD Panel<br>(IPS) | - |
| 2.2 | Viewing angle<br>(H, V) | H: 178°, V: 178° | H: 178°, V: 178° | - |
| 2.3 | Resolution | 8MP (4,096 x 2,160) | 8MP (4,096 x 2,160)<br>(4MP: 2,048 x 2,160<br>x2) | - |
| 2.4 | Aspect ratio | 17:9 (8.5 : 9 x 2) | 17:9 (8.5 : 9 x 2) | - |
| 2.5 | Active screen<br>size | 697.9 mm x 368.0 mm | 697.9 mm x 368.0 mm | - |
| 2.6 | Pixel pitch | 0.1704 mm x 0.1704<br>mm | 0.1704 mm x 0.1704<br>mm | - |
| 2.7 | Maximum<br>luminance | 850 cd/m² | 850 cd/m² | - |
| 2.8 | DICOM<br>calibrated<br>luminance | 500 cd/m² | 500 cd/m² | - |
| 2.9 | Contrast ratio | 1450:1 | 1450:1 | - |
| 2.10 | Response<br>Time (typ.) | 20 ms (On/Off) | 20 ms (On/Off) | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | Grayscale<br>Tones | From a palette of 68<br>billion colors:<br>- 10-bit input<br>(DisplayPort): 1.07<br>billion colors<br>(maximum)<br>- 8-bit input: 16.77<br>million colors | From a palette of 68<br>billion colors:<br>- 10-bit input<br>(DisplayPort): 1.07<br>billion colors<br>(maximum)<br>- 8-bit input: 16.77<br>million colors | - |
| 2.13 | Luminance<br>non-uniformity | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | - |
| 3 | Video Signal Input | | | |
| 3.1 | Input video signals | DVI-D (dual link) x 2, DisplayPort x 2 | DVI-D (dual link) x 2, DisplayPort x 2 (two inputs are required) | – |
| 3.2 | Scanning Frequency (H, V) | 31 - 140 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz) Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 140 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz) Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | – |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC24V/9.0A | AC 100 - 120V, 200 - 240 V: 50 / 60 Hz | The difference between Built-in power supply and Built-out power supply. |
| 4.2 | Power Consumption / Save Mode | 180 W / Less than 5 W | 227 W / Less than 6 W | Different design scheme. |
| 4.3 | Power Management | DVI DMPM, DisplayPort 1.2 | DVI DMPM, DisplayPort 1.1a | Different design scheme. |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor Manage | RadiCS | Different design scheme. |
| 5.2 | Sensor | Backlight Sensor, Integrated Front Sensor, Ambient Light Sensor | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor | – |
| 5.3 | USB Ports/Standard | 1. Upstream, 2. Downstream / Rev. 2.0 | 1.Upstream, 2.Downstream / Rev. 2.0 | – |
| 5.4 | Dimensions w/o stand (W x H x D) | 755 x 433.8 x 99.1 mm | 747 x 430 x 130 mm | Different housing design due to the different panel size. |

#### 8.2 Comparison table

#### Table 2 General Comparison

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C81W+.

#### 8.3 Performance Testing

According to the instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions, the bench tests were performed on C81W+ as below.

- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline).
- Measure the angle dependency of luminance response in horizontal, vertical and diaqonal directions.
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance.
- Measure the display reflections including specular, diffuse and haze components.
- Measure the small-spot contrast ratio.
- Measure the spatial resolution expressed as modulation transfer function (MTF).
- Measure the noise expressed as noise power spectrum (NPS).
- Measure the pixel aperture ratio.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the temporal response.
- The performance data on luminance stability
- Maximum number allowed for each type of pixel defects/faults

The test results showed that C81W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX850 except some items, each of which was determined that it would not affect observer's performance.

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No animal or clinical testing is needed for C81W+.

## 9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Shenzhen Beacon Display Technology Co., Ltd. concludes that:

- The intended use of C81W+ is totally same as that of the predicate device.
- The technological characteristics differences between C81W+ and RadiForce RX850 do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C81W+ are equivalent to those of the predicate device.