2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

K172815 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Oct 27, 2017 · Radiology

Device Facts

• Record ID: K172815
• Device Name: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) 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

2MP LCD monitor (monochrome and color models) for medical image display; inputs digital video signals (DVI-D, DisplayPort, VGA) from imaging systems; transforms signals into visual output via LED-backlit TFT LCD panels; features built-in brightness stabilization and anti-glare coating; used in clinical settings by trained medical practitioners for review, analysis, and diagnosis; output allows clinicians to visualize medical images for diagnostic decision-making; benefits include stable brightness and persistent calibration throughout device life.

Clinical Evidence

Bench testing only. No clinical or animal data. Testing verified conformance to DICOM GSDF and AAPM TG18 guidelines, including luminance/chromaticity non-uniformity, spatial resolution (MTF), and pixel defect analysis. Results demonstrated equivalence to predicate devices.

Technological Characteristics

21.3" TFT LCD panel (monochrome or color), LED backlight, 1600x1200 resolution, 1400:1 contrast ratio, 500 cd/m² typical brightness. Connectivity: DVI-D, DisplayPort, VGA. Power: DC 12V/6.0A. Features: anti-glare hard coating, brightness stabilization circuit, ambient light sensor, backlight sensor. VESA DDC 2B plug-and-play. Operating temp: 5°C-35°C.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review, analysis, and diagnosis. Contraindicated for the display of 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

• EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 (K120407)
• EIZO Corporation, 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR (K160247)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2017

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

### Re: K172815

Trade/Device Name: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 29, 2017 Received: September 18, 2017

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. 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 of medical 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Robert Oels

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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

#### K172815

Device Name

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

#### Indications for Use (Describe)

The 2MP LCD Monitor (G22S+, G22S+, C22S+, C22SP+) 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)

V 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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# 510(k) Summary

[As required by 21 CFR 807.92]

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

August 29, 2017

## 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: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Common Name: 2MP LCD Monitor Classification Name: Picture archiving and communications system 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 NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012).

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EIZO Corporation, 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR has been cleared by FDA through 510(k) No. K160247 (Decision Date - February 23, 2016).

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

Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.

Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.

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

The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) 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.

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

| Panel | 21.3", TFT, monochrome, LCD screen, anti-glare,<br>hard coating |
|-------------------|-----------------------------------------------------------------|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |

### G22S+/G22SP+ Monochrome LCD monitor

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| Native resolution | 1,200 x 1,600 | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------|--|
| Display area | 324 mm(H) x 432 mm (V) | |
| Aspect ratio | 3:4 | |
| Screen size | 21.3" real diagonal | |
| Power | DC 12 V/6.0 A | |
| Power consumption | Max. 40 W | |
| Input signals | DVI-D, Display Port, VGA | |
| Plug and play | VESA DDC 2B | |
| Dimension | 369 mm (W) x 506 ~ 626 mm (H) x 235 mm (D) (with stand)<br>369 mm (W) x 483 mm (H) x 65 mm (D) (without stand) | |
| Weight | 6.0 kg (without Stand)<br>9.2 kg (with Stand) | |
| Operating<br>temperature and<br>humidity | Temperature: 5°C ~ 35°C<br>Humidity: 15% ~ 85% | |
| Storage temperature<br>and humidity | Temperature: -20°C ~ 60°C<br>Humidity:10% ~ 90% | |

### C22S+/C22SP+ Color LCD monitor

| Panel | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
|-------------------|---------------------------------------------------------|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
| Native resolution | 1,200 x 1,600 |
| Display area | 324 mm(H) x 432 mm (V) |
| Aspect ratio | 3:4 |
| Screen size | 21.3" real diagonal |

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| Power | DC 12 V/6.0 A | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Power consumption | Max. 60 W | |
| Input signals | DVI-D, Display Port, VGA | |
| Plug and play | VESA DDC 2B | |
| Dimension | 369 mm (W) x 506 ~ 626 mm (H) x 235 mm (D) (with<br>stand)<br>369 mm (W) x 483 mm (H) x 65 mm (D) (without<br>stand) | |
| Weight | 6.0 kg (without Stand)<br>9.2 kg (with Stand) | |
| Operating<br>temperature and<br>humidity | Temperature: 5°C ~ 35°C<br>Humidity: 15% ~ 85% | |
| Storage temperature<br>and humidity | Temperature: -20°C ~ 60°C<br>Humidity:10% ~ 90% | |

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

### 8.1 Intended uses:

| ID | Comparison<br>Item | Proposed Device<br>2MP Monochrome LCD<br>Monitor (G22S+, G22SP+) | Predicate Device<br>2MP Monochrome LCD<br>Monitor (RadiForce GX240) |
|----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitor<br>(G22S+, G22SP+) is intended<br>to be used in displaying and<br>viewing digital images for<br>review, analysis and diagnosis<br>by trained medical<br>practitioners. It does not<br>support the display of<br>mammography images for<br>diagnosis. | The RadiForce GX240 is<br>intended to be used in displaying<br>and viewing digital images by<br>trained medical practitioners. The<br>RadiForce GX240 does not<br>support the display of<br>mammography images for<br>diagnosis. |

| | | | | | Table 1 Intended Use Comparison of G22S+/G22SP+ |
|--|--|--|--|--|--------------------------------------------------|
|--|--|--|--|--|--------------------------------------------------|

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| ID | Comparison Item | Proposed Device<br>2MP Color LCD Monitor<br>(C22S+, C22SP+) | Predicate Device<br>2MP Color LCD Monitor<br>(RX250, RX250-AR) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitor (C22S+,<br>C22SP+) is intended to be<br>used in displaying and viewing<br>digital images for review,<br>analysis and diagnosis by<br>trained medical practitioners. It<br>does not support the display of<br>mammography images for<br>diagnosis. | This product is intended to be<br>used in displaying and viewing<br>digital images for review, analysis<br>and diagnosis by trained<br>medical practitioners. It does not<br>support the display of<br>mammography images for<br>diagnosis. |

### Table 2 Intended Use Comparison of C22S+/C22SP+

## 8.2 Comparison table

| ID | Comparison<br>Item | Proposed Device<br>2MP Monochrome<br>LCD Monitor (G22S+,<br>G22SP+) | Predicate Device<br>2MP Monochrome<br>LCD Monitor<br>(RadiForce GX240) | Explanation of<br>Difference |
|------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen<br>Technology | Monochrome TFT<br>LCD Panel (IPS) | Monochrome TFT<br>LCD Panel (IPS) | - |
| 2.2 | Viewing angle<br>(H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - |
| 2.5 | Active screen<br>size | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - |
| 2.7 | Typical<br>luminance | 1900 cd/m² | 1200 cd/m² | Different screen |
| | | | | |
| 2.8 | DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | - |
| 2.9 | Contrast ratio | 1400:1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Grayscale Tones | 10-bit (DisplayPort):<br>1,024 from a palette of 16,369 tones<br>8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort):<br>1,024 from a palette of 16,369 tones<br>8-bit: 256 from a palette of 16,369 tones | - |
| 2.12 | Luminance non-uniformity compensation | - | Digital Uniformity Equalizer | Different design scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video signals | DVI-D x 1,<br>DisplayPort x 1,<br>VGA x 1 | DVI-D x 1,<br>DisplayPort x 1 | Different design scheme |
| 3.2 | Ouput video signals | - | DisplayPort x 1 (daisy chain) | Different design scheme |
| 3.3 | Scanning Frequency (H, V) | 31 - 100 kHz / 59 - 61 Hz<br>Frame synchronous mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz<br>Frame synchronous mode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 12 V/6.0 A | AC 100 -120 V, 200 - 240 V: 50 / 60 Hz | Difference between Built-in power supply and Built-out power supply |
| 4.2 | Power Consumption / Save Mode | 40 W/Less than 5 W | 76 W / Less than 1.6 W | Different design scheme |
| 4.3 | Power Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor<br>Manage | RadiCS | Different design<br>scheme |
| 5.2 | Sensors | G22S+:<br>Backlight Sensor,<br>Ambient Light Sensor<br><br>G22SP+:<br>Backlight Sensor,<br>Ambient Light Sensor<br>Integrated Front<br>Sensor | Backlight Sensor,<br>Presence Sensor,<br>Integrated Front<br>Sensor<br>Ambient Light<br>Sensor | Different design<br>scheme |
| 5.3 | USB<br>Ports/Standard | 1 upstream,<br>2 downstream | 1 upstream,<br>2 downstream | - |
| 5.4 | Dimensions<br>w/o stand (W x<br>H x D) | 369 x 483 x 65 mm | 376 x 505 x 98 mm | Different housing<br>design due to the<br>different panel<br>size |

#### Table 3 General Comparison of G22S+/G22SP+

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## Table 4 General Comparison of C22S+/C22SP+

| ID | Comparison<br>Item | Proposed Device<br>2MP Color LCD<br>Monitor (C22S+,<br>C22SP+) | Predicate Device<br>2MP Color LCD<br>Monitor<br>(RX250, RX250-AR) | Explanation of<br>Difference |
|------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen<br>Technology | IPS TFT Color LCD<br>Panel | IPS TFT Color LCD<br>Panel | - |
| 2.2 | Viewing angle<br>(H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - |
| 2.5 | Active screen<br>size | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - |
| | | | | |
| 2.7 | Typical<br>luminance | 900 cd/m² | 800 cd/m² | Different screen |
| 2.8 | DICOM<br>calibrated<br>luminance | 500 cd/m² | 400 cd/m² | Different screen |
| 2.9 | Contrast ratio | 1400 : 1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Display 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 | 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 | - |
| 2.12 | Luminance<br>non-uniformity<br>compensation | - | Digital Uniformity<br>Equalizer | Different design<br>scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video<br>signals | DVI-D x 1,<br>DisplayPort x 1,<br>VGA x 1 | DVI-D x 1,<br>DisplayPort x 1 | Different design<br>scheme |
| 3.2 | Ouput video<br>signals | - | - | - |
| 3.3 | Scanning<br>Frequency (H,<br>V) | 31 - 100 kHz / 59 - 61<br>Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61<br>Hz<br>(VGA Text: 69 - 71<br>Hz)<br>Frame synchronous<br>mode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power<br>Requirements | DC 12 V/6.0 A | AC 100 - 240 V: 50 /<br>60Hz | Difference<br>between Built-in<br>power supply<br>and Built-out<br>power supply |
| | | | | |
| 4.2 | Power<br>Consumption /<br>Save Mode | 60 W/Less than 5 W | 79 W / Less than 1.6<br>W | Different design<br>scheme |
| 4.3 | Power<br>Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor<br>Manage | RadiCS | Different design<br>scheme. |
| 5.2 | Sensors | C22S+:<br>Backlight Sensor,<br>Ambient Light Sensor<br>C22SP+:<br>Backlight Sensor,<br>Ambient Light Sensor<br>Integrated Front<br>Sensor | Backlight Sensor,<br>Presence Sensor | Different design<br>scheme |
| 5.3 | USB<br>Ports/Standard | 1 upstream,<br>2 downstream / Rev.<br>2.0 | 1 upstream,<br>2 downstream / Rev.<br>2.0 | - |
| 5.4 | Dimensions<br>w/o stand (W x<br>H x D) | 369 x 483 x 65 mm | 361 x 465 x 78 mm | Different housing<br>design due to the<br>different panel<br>size |

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the G22S+, G22SP+, C22S+, C22SP+.

### 8.3 Performance Testing

The bench tests were performed on G22S+, G22SP+, C22S+, C22SP+ 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 luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.

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- 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.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults

The test results showed that G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device, RadiForce GX240, RadiForce RX250 and RX250-AR except some items, each of which was determined that it would not affect observer's performance.

No animal or clinical testing is needed for G22S+, G22SP+, C22S+, C22SP+.

## 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 G22S+, G22SP+, C22S+, C22SP+ is totally same as that of the ● predicate device.
- The technological characteristics differences between G22S+, G22SP+, C22S+, C22SP+ and RadiForce GX240, RadiForce RX250 and RX250-AR do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of G22S+, G22SP+, C22S+, C22SP+ are equivalent to those of the predicate device.