Who is the manufacturer of 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+?

Shenzhen Beacon Display Technology Co., Ltd. filed the 510(k) submission for 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ (K201599).

What is the FDA product code for 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+?

PGY. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+?

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

Who can help prepare an FDA 510(k) submission like 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

K201599 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Jul 2, 2020 · Radiology

Device Facts

Record ID	K201599
Device Name	2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
Applicant	Shenzhen Beacon Display Technology Co., Ltd.
Product Code	PGY · Radiology
Decision Date	Jul 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended Use

The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.

Device Story

21.3-inch TFT LCD monitors (color or monochrome) designed for general radiography image display. Devices receive digital video input (DVI-D, DisplayPort, VGA) from medical imaging systems and render high-definition images. Integrated LED backlights and brightness stabilization circuits ensure consistent luminance and DICOM Part 3.14 compliance. Operated by trained medical practitioners in clinical settings to review and diagnose medical images. Output is a visual display of diagnostic data; aids clinical decision-making by providing calibrated, high-precision imaging. Some models (SP+ variants) include protective acryl glass with anti-reflection coating. Devices are standalone monitors; do not perform automated diagnostic analysis.

Clinical Evidence

Bench testing only. Evaluated conformance to DICOM GSDF, luminance/chromaticity non-uniformity, MTF spatial resolution, and pixel defect analysis per AAPM TG18 guidelines. No clinical or animal data required.

Technological Characteristics

21.3-inch TFT LCD (IPS); LED backlight; 1200x1600 native resolution; 3:4 aspect ratio; 1000-2000 cd/m² typical brightness; 1800:1 contrast ratio; 178° viewing angle. Connectivity: DVI-D, DisplayPort, VGA. Power: DC 12V/6.0A. Includes backlight and ambient light sensors. Calibration: DICOM Part 3.14. Sterilization: N/A.

Indications for Use

Indicated for trained medical practitioners to display and view digital 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

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

Related Devices

K233897 — 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) · Shenzhen Beacon Display Technology Co., Ltd. · Feb 6, 2024
K201211 — 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ · Shenzhen Beacon Display Technology Co., Ltd. · Sep 3, 2020
K161895 — 2MP Color LCD Monitor CCL214 (CL21214) · Jvckenwood Corporation · Sep 8, 2016
K170944 — LCD Monitor (MD310C, MD310G, MD210G) · Benq Corporation · May 25, 2017
K240310 — LCD Monitors C310S, G310S, C316S, G316S, C616W · Shenzhen Beacon Display Technology Co., Ltd. · Mar 29, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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 Bl, NanshanZhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA ### Re: K201599 Trade/Device Name: 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+ G2SP+, G23S+,G23SP+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: May 29, 2020 Received: June 12, 2020 July 2, 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ # 006_Indications for Use Statement {3}------------------------------------------------ {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201599 Device Name 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ #### Indications for Use (Describe) The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 007_510 (k) Summary {6}------------------------------------------------ # 510(k) Summary [As required by 21 CFR 807.92] #### 1. Date Prepared [21 CFR807.92 (a) (1)] K201599 May 29, 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 District, Shenzhen, 518055 China | | Contact Name: | Fu Ailing | | Telephone No.: | +86-0755-36868363-5150 | | Fax No.: | +86-0755-26995755 | | Email Address: | fuailing@beacon-display.cn | # 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)] | Trade Name/Model: | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ | |-----------------------|---------------------------------------------------------------------------------| | Common Name: | 2MP LCD Monitors C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ | | 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)] {7}------------------------------------------------ The identified predicates within this submission are as follows: 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). EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012). # 5. Description of the Device [21 CFR 807.92(a) (4)] C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/ grayscale monitors. They 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 panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen. Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional acryl glass, 2 means 2MP; 2 or 3 means a screen change. For example, C22S+ is a color LCD monitor; G22SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen, and G23SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen which is different with that of G22SP+. # 6. Intended Use [21 CFR 807.92(a)(5)] The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis. {8}------------------------------------------------ # 7. Technological Characteristics [21 CFR 807.92(a)(6)] | Panel | 21.3", TFT, color, LCD screen, anti-glare, hard coating | |----------------------------------|-------------------------------------------------------------------------------------------------------| | Brightness (Typ.) | 1000 cd/m² | | CR (Typ.) | 1800:1 | | Viewing angle | R/L 178°, U/D 178° 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 | | 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 511.15 ~ 596.15 mm (H) x 220 mm (D) (with stand) 608 x 561 x 327 mm (with packing) | | Weight | 8.0 ± 0.5 kg (Net) 11.0 ± 0.5 kg (Gross) | | Operating temperature and | Temperature: 0°C ~ 40°C Humidity: 15% ~ 85% | | Storage temperature and humidity | Temperature: -20°C ~ 60°C Humidity:10% ~ 90% | # C22S+/C22SP+ Color LCD monitor ## G22S+/G22SP+ Monochrome LCD monitor | Panel | 21.3", TFT, monochrome, LCD screen, anti-glare, | |-------------------|-------------------------------------------------| | Brightness (Typ.) | 2000 cd/m² | | CR (Typ.) | 1800:1 | | Viewing angle | R/L 178°, U/D 178° 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 | {9}------------------------------------------------ | Power | DC 12 V/6.0 A | |-------------------------------------|---------------------------------------------------------------------------------| | Power consumption | Max. 50 W | | Input signals | DVI-D, Display Port, VGA | | Plug and play | VESA DDC 2B | | Dimension | 369 x 511.5 ~ 596.15 x 220 mm (with stand) 608 x 561 x 327 mm (with packing) | | Weight | 8.0 ± 0.5 kg (Net) 11.0 ± 0.5 kg (Gross) | | Operating temperature and | Temperature: 0°C ~ 40°C Humidity: 15% ~ 85% | | Storage temperature and humidity | Temperature: -20°C ~ 60°C Humidity:10% ~ 90% | ## G23S+/G23SP+ Monochrome LCD monitor | Panel | 21.3", TFT, monochrome, LCD screen, anti-glare, | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Brightness (Typ.) | 1900 cd/m² | | CR (Typ.) | 1800:1 | | Viewing angle | R/L 178°, U/D 178° 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 | | Power | DC 12 V/6.0 A | | Power consumption | Max. 50 W | | Input signals | DVI-D, Display Port, VGA | | Plug and play | VESA DDC 2B | | Dimension | 369 mm (W) x 511.5 ~ 596.15 mm (H) x 220 mm (D) (with stand) 608 mm (W) x 561 mm (H) x 327 mm (D) (with packing) | | Weight | 8.0 ± 0.5 kg (Net) 11.0 ± 0.5 kg (Gross) | | Operating temperature and humidity | Temperature: 0°C ~ 40°C Humidity: 15% ~ 85% | | Storage temperature and humidity | Temperature: -20°C ~ 60°C Humidity:10% ~ 90% | {10}------------------------------------------------ # 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] ## 8.1 Intended use: | ID | Comparison Item | Proposed Device 2MP Color LCD Monitors (C22S+, C22SP+) | Predicate Device 2MP Color LCD Monitor (RX250, RX250-AR) | |----|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Intended Use | The 2MP LCD Monitors C22S+, C22SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis. | This product is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis. | ## Table 1 Intended Use Comparison of C22S+/C22SP+ ## Table 2 Intended Use Comparison of G22S+, G22SP+, G23S+, G23SP+ | ID | Comparison ltem | Proposed Device 2MP Monochrome LCD Monitors (G22S+, G22SP+, G23S+, G23SP+) | Predicate Device 2MP Monochrome LCD Monitor (RadiForce GX240) | |----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Intended Use | The 2MP LCD Monitors G22S+, G22SP+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners.The monitors do not support the display of mammography images for diagnosis. | The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis. | {11}------------------------------------------------ # 8.2 Comparison table | Table 3 General Comparison of C22S+/C22SP+ | |---------------------------------------------| |---------------------------------------------| | ID | Comparison Item | Proposed Device 2MP Color LCD Monitors (C22S+, C22SP+) | Predicate Device 2MP Color LCD Monitor (RX250, RX250-AR) | Explanation of Difference | |------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | 2 | Display Performance/Specifications | | | | | 2.1 | Screen Technology | IPS TFT Color LCD Panel | IPS TFT Color LCD Panel | - | | 2.2 | Viewing angle (H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen | | 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 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 luminance | 1000 cd/m² | 800 cd/m² | Different screen | | 2.8 | DICOM calibrated luminance | 500 cd/m² | 400 cd/m² | Different screen | | 2.9 | Contrast ratio | 1800 : 1 | 1400 : 1 | Different screen | | 2.10 | Backlighting | LED | LED | - | | 2.11 | Display Colors | From a palette of 1.07 billion colors: - 10-bit input (DisplayPort): 1.07 billion colors (maximum) - 8-bit input: 16.77 million colors | From a palette of 68 billion colors: - 10-bit input (DisplayPort): 1.07 billion colors (maximum) - 8-bit input: 16.77 million colors | Different screen | | 2.12 | Luminance non-uniformity compensation | - | Digital Uniformity Equalizer | Different design scheme | | 3 | Video Signals | | | | | 3.1 | Input video signals | DVI-D x 1, DisplayPort x 1, VGA x 1 | DVI-D x 1, DisplayPort x 1 | Different design scheme | | 3.2 | Ouput video signals | - | - | - | | 3.3 | Scanning Frequency (H, V) | 31 - 82 kHz / 59 - 61 Hz Frame synchronous mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz) Frame synchronous mode: 59 - 61 Hz | - | | 4 | Power Related Specifications | | | | | 4.1 | Power Requirements | DC 12 V/6.0 A | AC 100 - 240 V: 50 / 60Hz | Difference between Built-in power supply and Built-out power supply | | 4.2 | Power Consumption / Save Mode | 60 W/Less than 5 W | 79 W / Less than 1.6 W | Different design scheme | | 4.3 | Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a | - | | 5 | Miscellaneous Features/Specifications | | | | | 5.1 | QC software | Beacon Monitor Manage | RadiCS | Different design scheme | | 5.2 | Sensors | C22S+: Backlight Sensor, Ambient Light Sensor C22SP+: Backlight Sensor, Ambient Light Sensor Integrated Front Sensor | Backlight Sensor, Presence Sensor | Different design scheme | | 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) | 365 x 478 x 75 mm | 361 x 465 x 78 mm | Different housing design due to the different panel size | {12}------------------------------------------------ {13}------------------------------------------------ ## Table 4 General Comparison of G22S+/G22SP+ | ID | Comparison Item | Proposed Device 2MP Monochrome LCD Monitors (G22S+, G22SP+) | Predicate Device 2MP Monochrome LCD Monitor (RadiForce GX240) | Explanation of Difference | | |------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--| | 2 | | Display Performance/Specifications | | | | | 2.1 | Screen Technology | Monochrome TFT LCD Panel (IPS) | Monochrome TFT LCD Panel (IPS) | - | | | 2.2 | Viewing angle (H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen | | | 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 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 luminance | 2000 cd/m² | 1200 cd/m² | Different screen | | | 2.8 | DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | - | | | 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | | | 2.10 | Backlighting | LED | LED | - | | | | | | | | | | 2.11 | Grayscale Tones | 10-bit (DisplayPort): 1,024 from a palette of 1,024 tones 8-bit: 256 from a palette of 1,024 tones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones 8-bit: 256 from a palette of 16,369 tones | Different screen | | | 2.12 | Luminance non-uniformity compensation | - | Digital Uniformity Equalizer | Different design scheme | | | 3 | Video Signals | | | | | | 3.1 | Input video signals | DVI-D x 1, DisplayPort x 1, VGA x 1 | DVI-D x 1, 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 - 82 kHz / 59 - 61 Hz Frame synchronous mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz 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 | 50 W/Less than 5 W | 76 W / Less than 1.6 W | Different design scheme | | | 4.3 | Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a | | | | 5 | Miscellaneous Features/Specifications | | | | | | 5.1 | QC software | Beacon Monitor Manage | RadiCS | Different design scheme | | | 5.2 | Sensors | G22S+: Backlight Sensor, Ambient Light Sensor G22SP+: Backlight Sensor, Ambient Light Sensor Integrated Front Sensor | Backlight Sensor, Presence Sensor, Integrated Front Sensor Ambient Light Sensor | Different design scheme | | | 5.3 | USB Ports/Standard | 1 upstream, 2 downstream | 1 upstream, 2 downstream | - | | | 5.4 | Dimensions w/o stand (W x H x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housing design due to the different panel size | | {14}------------------------------------------------ {15}------------------------------------------------ ## Table 5 General Comparison of G23S+/G23SP+ | ID | Comparison Item | Proposed Device 2MP Monochrome LCD Monitors (G23S+, G23SP+) | Predicate Device 2MP Monochrome LCD Monitor (RadiForce GX240) | Explanation of Difference | | |------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--| | 2 | | Display Performance/Specifications | | | | | 2.1 | Screen Technology | Monochrome TFT LCD Panel (IPS) | Monochrome TFT LCD Panel (IPS) | - | | | 2.2 | Viewing angle (H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen | | | 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 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 luminance | 1900 cd/m² | 1200 cd/m² | Different screen | | | 2.8 | DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | | | | 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | | | 2.10 | Backlighting | LED | LED | | | | 2.11 | Grayscale Tones | 10-bit (DisplayPort): 1,024 from a palette of 1,024 tones 8-bit: 256 from a palette of 1,024 tones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones 8-bit: 256 from a palette of 16,369 tones | Different screen | | | 2.12 | Luminance non-uniformity compensation | | Digital Uniformity Equalizer | Different design scheme | | | 3 | Video Signals | | | | | | 3.1 | Input video signals | DVI-D x 1, DisplayPort x 1, VGA x 1 | DVI-D x 1, 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 - 82 kHz / 59 - 61 Hz Frame synchronous mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz 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 | 50 W/Less than 5 W | 76 W / Less than 1.6 W | Different design scheme | | | 4.3 | Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a | | | | 5 | Miscellaneous Features/Specifications | | | | | | 5.1 | QC software | Beacon Monitor Manage | RadiCS | Different design scheme | | | 5.2 | Sensors | G23S+: Backlight Sensor, Ambient Light Sensor G23SP+: Backlight Sensor, Ambient Light Sensor Integrated Front Sensor | Backlight Sensor, Presence Sensor, Integrated Front Sensor Ambient Light Sensor | Different design scheme | | | 5.3 | USB Ports/Standard | 1 upstream, 2 downstream | 1 upstream, 2 downstream | - | | | 5.4 | Dimensions w/o stand (W x H x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housing design due to the different panel size | | {16}------------------------------------------------ {17}------------------------------------------------ It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C22S+, G22S+, G22S+, G22SP+, G23S+, G23SP+. ## 8.3 Performance Testing The bench tests were performed on C22S+, C22SP+, G22SP+, G22SP+, G23SP+ 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. - 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 {18}------------------------------------------------ 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 C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are with display characteristics equivalent to those of the predicate device. RadiForce RX250 and RX250-AR, and RadiForce GX240 except some items, each of which was determined that it would not affect observer's performance. No animal or clinical testing is needed for C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+. # 9. Conclusion [21 CFR 807.92(b) (3)] In accordance with the Federal Food, Druq 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 C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are totally same as those of the predicate devices. - The technological characteristics differences between C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ and RadiForce RX250 and RX250-AR, RadiForce GX240 do not affect the safety and effectiveness, so no new risk is raised. - Demonstrated by the bench tests, the display characteristics of C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are equivalent to those of the predicate devices.