3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

K201211 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Sep 3, 2020 · Radiology

Device Facts

• Record ID: K201211
• Device Name: 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Sep 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

Device Story

3MP LCD monitors (color and monochrome) designed for high-definition medical imaging. Input: digital radiological images via DVI-D or DisplayPort. Operation: LED-backlit TFT panels with built-in brightness stabilization circuits; continuous calibration to DICOM Part 3.14 standards. Output: high-precision visual display for review, analysis, and diagnosis. Used in clinical settings by trained medical practitioners. Features include anti-reflection/anti-scratch glass (SP+ models), ambient light sensors, and integrated front sensors for luminance control. Benefits: provides stable, high-precision image quality for diagnostic accuracy. Healthcare providers use the display to view images; output directly informs clinical decision-making.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Testing verified conformance to DICOM GSDF, luminance non-uniformity, stability across temperatures (0°C, 25°C, 40°C), viewing angle performance, temporal response, spatial noise (NPS), MTF, pixel defects, and color tracking.

Technological Characteristics

21.3" TFT LCD (color or monochrome); 1536 x 2048 resolution; LED backlight (50,000h life); 1500:1 contrast ratio; 60Hz refresh rate. Connectivity: DVI-D, DisplayPort, USB 2.0. Sensors: Backlight, front, and ambient light. Power: 12V DC. Housing: Plastic, IP20 (IP65 front for SP+ models). Standards: IEC60601-1, EN60601-1, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 NO. 60601-1. Calibration: Beacon Monitor Manage software.

Indications for Use

Indicated for trained medical practitioners to display radiological images (C32S+/C32SP+) or digital images for X-ray/MRI diagnosis (G32S+/G32SP+). Not indicated for mammography.

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, RadiForce RX360, RX360-AR (K182591)
• EIZO NANAO Corporation, 3MP Monochrome LCD Monitor, RadiForce GX340 (K113784)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

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

Re: K201211

Trade/Device Name: 3MP Color LCD Monitors C32S+, C32SP+, 3MP Monochrome LCD Monitors G32S+, G32SP+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 28, 2020 Received: August 6, 2020

September 3, 2020

Dear Fu Ailing:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K201211

Device Name

3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

#### Indications for Use (Describe)

The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

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

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K201211

# 510(k) Summary

[As required by 21 CFR 807.92]

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

April 15, 2020

### 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: 3MP Color LCD Monitors C32S+, C32SP+;

3MP Monochrome LCD Monitors G32S+, G32SP+

- Common Name: 3MP LCD Monitors C32S+, C32SP+, G32S+, G32SP+
Classification Name: Picture archiving and communications system

Requlation Number: 21 CFR 892.2050

Product code: PGY

Classification Panel: Radiology

Device Class: Il

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

The identified predicate within this submission is as follows:

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EIZO Corporation, RadiForce RX360, RX360-AR has been cleared by FDA through 510(k) No. K182591 (Decision Date - October 18, 2018).

EIZO NANAO Corporation, 3MP Monochrome LCD Monitor, RadiForce GX340 has been cleared by FDA through 510(k) No. K113784 (Decision Date - May 4, 2012).

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

3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.

The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.

Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.

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

The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.

The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

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

| Monitor characteristics: | | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating | |
| Active area(H x V) | 324.86 x 433.15 mm | |
| Pixel pitch | 0.2115 mm (H) x 0.2115 mm (V) | |
| Resolution | 1536 x 2048 | |
| Contrast ratio | 1500:1 (typical), 1200:1 (minimal) | |
| Viewing angle (CR > 10 ) | Horizontal: 178° (typical) | |
| | Vertical: 178° (typical) | |
| Screen brightness | 1000 cd/m² (typical) | |
| Refresh rate | 60 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50000 hours | |
| Response time (Ton + Toff) | 25 ms (typical) | |
| Power supply: | | |
| Line voltage | 12 V | |
| Current consumption | 6.67 A | |
| Power consumption | 80 W (maximum) | |
| Standby | < 5 W | |
| Adaptor | 1:GSM90A12 Input: 100~240V, 1.3-0.6A, 50/60Hz,<br>Output: +12VDC, 6.67A<br>2:GSM120A12 Input: 100~240V, 1.4-0.7A, 50/60Hz,<br>Output: +12VDC, 8.5A | |
| Control and connection: | | |
| Front | 1 operation LED, 6 functional keys | |
| Back | Ground*1 Power switch*1 DVI-D*1 DP*1 USB Upstream Port*1 USB Downstream Port*2 | |
| Mechanical characteristics : | | |
| Housing components | Plastic | |
| Ventilation openings | Natural heat radiation | |
| | | |
| Protection level | IP 20 | |
| | IP 65 (Applicable to the front of C32SP+) | |
| Climatic conditions : | | |
| Working temperature | 0°C - 40°C | |
| Working humidity | 15% - 85% Relative humidity, no condensation | |
| Working atmospheric | 700 hPa - 1060 hPa | |
| Transport and storage | -20°C - 60°C | |
| Transport and storage | 10% - 90% Relative humidity, no condensation | |
| Transport and storage | 700 hPa - 1060 hPa | |
| Safety regulations : | | |
| Safety standards | IEC60601-1, EN60601-1 | |
| | ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1 | |
| | CAN/CSA-C22.2 NO. 60601-1 | |
| Conformity | CCC, CE, TUV, FCC | |
| Dimension: | | |
| Dimensions (W x H x D) in | 369 x 511.5 ~ 596.15 x 220 mm | |
| With packing (W x H x D) | 608 x 561 x 327 mm | |
| Weight : | | |
| Net weight | 9.5 ± 0.5 kg | |
| Gross weight | 11.0 ± 0.5 kg | |

### C32S+, C32SP+ Color LCD Monitors

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### G32S+, G32SP+ Monochrome LCD monitors

| Monitor characteristics: | |
|------------------------------|-----------------------------------------------------|
| Screen technology | 21.3", TFT, grayscale, LCD screen, anti-glare, hard |
| Active area( H x V) | 324.86 x 433.15 mm |
| Pixel pitch | 0.2115 mm (H) x 0.2115 mm (V) |
| Resolution | 1536 x 2048 |
| Contrast ratio | 1500:1 (typical), 1200:1 (minimal) |
| Viewing angle ( CR > 10 ) | Horizontal: 170° (typical) |
| | Vertical: 170° (typical) |
| Screen brightness | 2000 cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50000 hours |
| Response time ( Ton + Toff ) | 28 ms (typical) |

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| Power supply: | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Line voltage | 12 V |
| Current consumption | 6.67 A |
| Power consumption | 50 W (maximum) |
| Standby | < 5 W |
| Adaptor | 1:GSM90A12 Input: 100~240V, 1.3-0.6A, 50/60Hz<br>Output: +12VDC, 6.67A<br>2:GSM120A12 Input: 100~240V, 1.4-0.7A, 50/60Hz<br>Output: +12VDC, 8.5A |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| Back | Ground*1 Power switch*1 DVI-D*1 DP*1 USB Upstream Port*1 USB Downstream Port*2 |
| Mechanical characteristics : | |
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Protection level | IP 20 |
| Climatic conditions : | |
| Working temperature | 0℃ - 40℃ |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Working atmospheric | 700 hPa - 1060 hPa |
| Transport and storage | -20℃ - 60℃ |
| Transport and storage | 10% - 90% Relative humidity, no condensation |
| Transport and storage | 700 hPa - 1060 hPa |
| Safety regulations : | |
| Safety standards | IEC60601-1, EN60601-1 |
| Conformity | CCC, CE, TUV, FCC |
| Dimension: | |
| Dimensions (W x H x D) in | 369 x 511.15 ~ 596.15 x 220 mm |
| With packing (W x H x D) | 608 x 561 x 327 mm |
| Weight : | |
| Net weight | 9.0 ± 0.5 kg |
| Gross weight | 11.0 ± 0.5 kg |

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

### 8.1 Intended uses:

| ID | Comparison<br>Item | Proposed Device<br>3MP Color LCD Monitors<br>C32S+, C32SP+ | Predicate Device<br>3MP Color LCD Monitor<br>RadiForce RX360, RX360-AR |
|----|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 3MP Color LCD Monitors<br>C32S+, C32SP+ are indicated for<br>use in displaying radiological<br>images for review, analysis, and<br>diagnosis by trained medical<br>practitioners. The displays are<br>not intended for mammography. | The Product is indicated for use<br>in displaying radiological images<br>for review, analysis, and<br>diagnosis by trained medical<br>practitioners. The display is not<br>intended for mammography. |

#### Table 1 Intended Use Comparison of C32S+, C32SP+

#### Table 2 Intended Use Comparison of G32S+, G32SP+

| ID | Comparison<br>ltem | Proposed Device<br>3MP Monochrome LCD<br>Monitors<br>G32S+, G32SP+ | Predicate Device<br>3MP Monochrome LCD<br>Monitor<br>RadiForce GX340 |
|----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Intended Use | The 3MP Monochrome LCD<br>Monitors G32S+, G32SP+ are<br>intended to be used in displaying<br>and viewing digital images for<br>diagnosis of X-ray or MRI, etc. by<br>trained medical practitioners. The<br>devices are not specified for<br>digital mammography systems. | The RadiForce GX340 is<br>intended to be used in<br>displaying and viewing digital<br>images for diagnosis of X-ray or<br>MRI, etc. by trained medical<br>practitioners. The device is not<br>specified for digital<br>mammography system. |

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#### 8.2 Comparison table

#### Table 3 General Comparison of C32S+, C32SP+

| ID | Comparison<br>Item | Proposed Device<br>3MP Color LCD Monitors<br>C32S+, C32SP+ | Predicate Device<br>3MP Color LCD Monitor<br>RadiForce RX360,<br>RX360-AR | Explanation of Differences | | |
|------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Display Performance/Specifications | | | | | |
| 3.1 | Display technology | Color (IPS) | Color (IPS) | - | | |
| 3.2 | Screen size | 54.1cm/21.3"<br>Aspect ratio:3:4 | 54.1cm/21.3"<br>Aspect ratio:3:4 | - | | |
| 3.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | - | | |
| 3.4 | Native resolution | 1536 x 2048 | 1536 x 2048 | - | | |
| 3.5 | Viewable image size<br>(H x V) | 324.86 x 433.15 mm | 324.9 x 433.2 mm | - | | |
| 3.6 | Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | - | | |
| 3.7 | Response time<br>(typical) | 25 ms (on / off) | 12 ms (on / off) | Different screen | | |
| 3.8 | Brightness (typical) | 1000 cd/m² | 1100 cd/m² | Different screen | | |
| 3.9 | Recommended<br>brightness for | 500 cd/m² | 500 cd/m² | - | | |
| 3.10 | Contrast ratio (typical) | 1500:1 | 1500:1 | - | | |
| 3.11 | Backlight type | LED | LED | - | | |
| 3.12 | Display colors | 10-bit (DisplayPort): 1.073<br>billion<br>1024 from a palette of 16,384<br>tones<br>8-bit(DVI): 16.77 million 256<br>from a palette of 16,384 tones | 10-bit colors (DisplayPort) :<br>1.07 billion (maximum) colors<br>8-bit colors: 16.77 million from<br>a palette of 543 billion colors | Tone between the predicate<br>device and our proposed<br>devices are different. But they<br>pass the exams in AAPM-TG18<br>4.3 "Luminance Response".<br>Therefore, they are equivalent<br>to the predicate device. | | |
| | Video Signals | | | | | |
| 4.1 | Input video signals | DVI-D (dual link) x 1,<br>DisplayPort x 1 | DVI-D (dual link) x 1,<br>DisplayPort x 2 | Different design scheme | | |
| 4.2 | Digital Scanning<br>Frequency (H, V) | 31 - 97 kHz/59 - 61 Hz | 31 - 127 kHz/29 - 61.5 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous mode:<br>29.5 - 30.5 Hz, 59 - 61 Hz | Different design scheme | | |
| 4.3 | Video bandwidth | DVI: 216 MHz<br>DisplayPort: 216 MHz | DVI: 215MHz<br>DisplayPort: 215MHz | Different design scheme | | |
| | Power Related Specifications | | | | | |
| 5.1 | Power Requirements | DC 12 V / 6.67 A | AC 100 - 240 V:50 / 60 Hz | Difference between built-in<br>power supply and built-out<br>power supply | | |
| 5.2 | Maximum power<br>consumption | 80 W | 74 W | Different design scheme | | |
| 5.3 | Power save mode | Less than 5 W | 1 W or less | Different design scheme | | |
| 5.4 | Power Management | DVI DMPM, DisplayPort 1.2 | DVI DMPM, DisplayPort 1.1a | Different design scheme | | |
| | Miscellaneous Features/Specifications | | | | | |
| 6.1 | Quality-control<br>Software | Beacon Monitor Manage | RadiCS | Different design scheme | | |
| 6.2 | Sensors | Backlight sensor<br>Integrated front sensor<br>Ambient light sensor | Backlight sensor<br>Integrated front sensor<br>Presence sensor<br>Ambient light sensor | Different design scheme | | |
| 6.3 | Luminance calibration<br>tools | Integrated optical sensor<br>External optical sensor<br>Calibration software: Beacon<br>Monitor Manage | Integrated optical sensor<br>External optical sensor<br>Calibration software:<br>RadiCS | Different design scheme | | |
| 6.4 | USB Ports | Upstream<br>USB 2.0: Type-B x 1 | Upstream<br>USB 2.0: Type-B x 2 | Different design scheme | | |
| 6.5 | Brightness<br>stabilization | Yes | Yes | - | | |
| 6.6 | Digital uniformity<br>equalizer | Yes | Yes | - | | |
| 6.7 | Net weight | 9.5 | 8 | Different weight due to different<br>components and parts | | |
| 6.8 | Hole Spacing (VESA<br>Standard) | 100 x 100mm | 100 x 100mm | - | | |
| 6.9 | Dimensions w/o stand<br>(W x H x D) | 369 x 220 x 511.5 ~ 596.15 | 341.3 x 200 x 481.5 - 571.5 | Different housing design due to<br>the different panel size | | |
| ID | Comparison<br>Item | Proposed Device<br>3MP Monochrome LCD<br>Monitors<br>G32S+, G32SP+ | Predicate Device<br>3MP Monochrome LCD<br>Monitor<br>RadiForce GX340 | Explanation of Differences | | |
| | Display Performance/Specifications | | | | | |
| 3.1 | Display technology | TFT Monochrome LCD Panel<br>(IPS) | TFT Monochrome LCD Panel<br>(IPS) | - | | |
| 3.2 | Screen size | 54 cm / 21.3" (541 mm<br>diagonal) | 54 cm / 21.3" (541 mm<br>diagonal) | - | | |
| 3.3 | Viewing angle (H/V) | 170°/170° | 176°/176° | Different screen | | |
| 3.4 | Native resolution | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | - | | |
| 3.5 | Viewable image size<br>(H x V) | 324.86 x 433.15 mm | 324.8 x 433.1 mm | - | | |
| 3.6 | Pixel pitch | 0.2115 mm (H) x 0.2115 mm | 0.2115 x 0.2115 mm | - | | |
| 3.7 | Response time<br>(typical) | 28 ms (On/Off) | 40 ms (On/Off) | Different screen | | |
| 3.8 | Brightness (typical) | 2000 cd/m² | 1200 cd/m² | Different screen | | |
| 3.9 | Recommended<br>brightness for | 500 cd/m² | 500 cd/m² | - | | |
| 3.10 | Contrast ratio (typical) | 1500:1 | 1400:1 | Different screen | | |
| 3.11 | Backlight type | LED | LED | - | | |
| 3.12 | Grayscale Tones | 10-bit (DisplayPort): 1,024<br>from a palette of 16,384 tones<br>8-bit (DVI): 256 from a palette<br>of 16,384 tones | 10-bit (DisplayPort): 1,024<br>from a palette of 16,369 tones<br>8-bit: 256 from a palette of<br>16,369 tones | Tone between the predicate<br>device and our proposed<br>devices are different. But theyAAPM-TG18 4.3 "Luminance<br>Response". Therefore, they<br>are equivalent to the predicate<br>device. | | |
| | Video Signals | | | | | |
| 4.1 | Input video signals | DVI-D (dual link) x 1<br>DisplayPort x 1 | DVI-D (dual link) x 1<br>DisplayPort x 1 | - | | |
| 4.2 | Digital Scanning<br>Frequency (H, V) | 31 - 97 kHz, 60 - 70 kHz | 31 - 127 kHz, 29.5 - 61 Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous mode:<br>29.5 - 30.5 Hz, 59 - 61 Hz | Different design scheme | | |
| 4.3 | Dot Clock | 216 MHz | 215 MHz | Different design scheme | | |
| | Power Related Specifications | | | | | |
| 5.1 | Power Requirements | DC 12 V / 6.67 A | AC 100 - 120 V, 200 - 240 V:<br>50 / 60 Hz | Difference between built-in<br>power supply and built-out<br>power supply | | |
| 5.2 | Maximum power<br>consumption | 50 W | 90 W | Different design scheme | | |
| 5.3 | Power save mode | Less than 5 W | Less than 1.6 W | Different design scheme | | |
| 5.4 | Power Management | DVI DMPM, DisplayPort 1.2 | DVI DMPM, DisplayPort 1.1a | Different design scheme | | |
| | Miscellaneous Features/Specifications | | | | | |
| 6.1 | Quality-control<br>procedures | Beacon Monitor Manage | RadiCS | Different design scheme | | |
| 6.2 | Sensors | Backlight Sensor<br>Integrated Front Sensor<br>Ambient Light Sensor | Backlight Sensor<br>Integrated Front Sensor<br>Presence Sensor<br>Ambient Light Sensor | Different design scheme | | |
| 6.3 | Luminance calibration<br>tools | Integrated optical sensor<br>External optical sensor<br>Calibration software: Beacon<br>Monitor Manage | Integrated optical sensor<br>External optical sensor<br>Calibration software:<br>RadiCS | Different design scheme | | |
| 6.4 | USB Ports | 1 upstream<br>2 downstream / Rev. 2.0 | 1 upstream<br>2 downstream / Rev. 2.0 | - | | |
| 6.5 | Brightness<br>stabilization | Yes | Yes | - | | |
| 6.6 | Digital uniformity<br>equalizer | Yes | Yes | - | | |
| 6.7 | Net weight | 9.0 kg | 10.2 kg | Different weight due to different<br>components and parts | | |
| 6.8 | Hole Spacing (VESA<br>Standard) | VESA standard 100 x 100 mm | VESA standard 100 x 100 mm | - | | |
| 6.9 | Dimensions w/o stand<br>(W x H x D) | 369 x 511.15 ~ 596.15 x 220 | 376 x 520~599 x 245.5 | Different housing design due to<br>the different panel size | | |

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510(k) Submission

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#### Table 4 General Comparison of G32S+/G32SP+

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510(k) Submission

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C32S+, C32SP+, G32S+, G32SP+.

#### 8.3 Performance Testing Comparation

The bench tests were performed on the proposed devices C32S+, C32SP+, G32S+, G32SP+ as below.

- 1) Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline).
- 2) Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- 3) Measure the luminance stability with the temperature 0 ℃ , 25 ℃ and 40 ℃ on Luminance response by AAPM-TG18.
- 4) Measure the luminance at the angles of 30° and 45° in diagonal, horizontal and vertical directions at center and four corners by AAPM-TG18.
- 5) Measure the temporal response using the typical data provided by the panel manufacturer.
- 6) Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 quideline.
- 7) Measure the spatial noise by noise power spectrum.
- 8) Measure the spatial resolution expressed as modulation transfer function (MTF)
- 9) Maximum number allowed for each type of pixel defects/faults
- 10) Meausure the maximum, minimum, achievable, and recommended luminance.
- 11) Measure the color tracking (primary colors and color gamut).

The test results showed that C32S+, C32SP+, G32S+, G32SP+ are with display characteristics equivalent to those of the predicate devices, RadiForce RX360, RX360-AR and 3MP Monochrome LCD Monitor, RadiForce GX340 except some items, each of which was determined that it would not affect observer's performance. No animal or clinical testing is needed for C32S+, C32SP+, G32S+, G32SP+.

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### 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 uses of C32S+, C32SP+, G32S+, G32SP+ are totally same as those of the predicate devices.
- The technological characteristics differences between C32S+, C32SP+, G32S+, G32SP+ 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 C32S+, C32SP+, G32S+, G32SP+ are equivalent to those of the predicate devices.