5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)

K233897 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Feb 6, 2024 · Radiology

Device Facts

• Record ID: K233897
• Device Name: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: PGY · Radiology
• Decision Date: Feb 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Device Story

5MP LCD monitors (color and monochrome) designed for high-definition medical image display; used in radiology environments (PACS, mammography, tomosynthesis). Devices receive video input (DVI-D, DisplayPort) from medical imaging systems; transform signals into high-resolution (2560 x 2048) visual output on TFT LCD panels. Features include LED backlighting, brightness stabilization circuits, and anti-glare coatings. Operated by trained medical practitioners/certified personnel. Output used for diagnostic interpretation of medical images; aids clinical decision-making by providing calibrated, high-precision visualization. Benefits include consistent image quality, stable luminance, and compliance with DICOM Part 3.14 standards.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Testing verified conformance to DICOM GSDF, AAPM Task Group 18 (TG18) guidelines for luminance response, non-uniformity, chromaticity, temporal response, spatial noise, reflection, veiling glare, and MTF.

Technological Characteristics

21.3-inch TFT LCD panels (color/monochrome); 2560 x 2048 resolution; LED backlighting; 50 Hz refresh rate; 2000:1 typical contrast ratio. Connectivity: DVI-D, DisplayPort, USB. Power: 24V DC. Calibration: Built-in front, ambient light, and backlight sensors. Compliance: IEC 60601-1, IEC 60601-1-2, DICOM Part 3.14. Housing: Plastic, IP20 protection.

Indications for Use

Indicated for trained medical practitioners or certified personnel to display and view medical images for diagnosis, specifically in digital mammography PACS, digital breast tomosynthesis, and FFDM modalities.

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

• JVC Kenwood Corporation, 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (K191137)

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Beacon Display Technology Co., Ltd. Li Yafei Official Correspodent 15F, Building 6, Hengda Shishang Huigu (East) Fulong Road, Dalang Subdistrict, Longhua Shenzhen, Guangdong 518109, China

February 6, 2024

#### Re: K233897

Trade/Device Name: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S. CB5MP, MB5MP, C516S, G516S) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PGY Dated: December 11, 2023 Received: December 11, 2023

Dear Li Yafei:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K233897

#### Device Name

5MP Color LCD Monitors C510S, CB5MP, C516S. 5MP Monochrome LCD Monitors G510S, MB5MP, G516S.

#### Indications for Use (Describe)

C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Type of Use (Select one or both, as applicable)

| × Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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)]

Feb 04, 2024

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

| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | 15F, Building 6, Hengda Shishang Huigu(East), Fulong Road, Dalang<br>Subdistrict, Longhua, Shenzhen, 518109 China |
| Contact Name: | Li Yafei |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |
| Email Address: | [e-mail] |

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

| ● Trade Name/Model: | 5MP Color LCD Monitors C510S, CB5MP, C516S.<br>5MP Monochrome LCD Monitors G510S, MB5MP, G516S. |
|-------------------------|-------------------------------------------------------------------------------------------------|
| ● Common Name: | 5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S,<br>G516S |
| ● Classification Name: | Medical image management and processing 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)]

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The identified predicate within this submission is as follows:

JVC Kenwood Corporation, 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 has been cleared by FDA through 510(k) No. K191137 (Decision Date -July 2, 2019).

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

5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography.

These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

C510S, CB5MP, C516S have the same color LCD panel and similar functionality. The difference between C510S and CB5MP is only different customers which results in the two models. For C510S, CB5MP, C516S, the difference is the main board and design principle.

G510S, MB5MP, G516S have the same monochrome LCD panel and similar functionality. The difference between G510S and MB5MP is only different customers which results in the two models. For G510S, MB5MP, G516S, the difference is the main board and design principle.

## 6. Indications for use

C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

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

| Panel characteristics: | |
|-------------------------|-----------------------------------------------------------------------|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
| Active area (H x V) | 422.4 x 337.92 mm |
| Pixel pitch | 0.165 mm (H) x 0.165 mm (V) |
| Resolution | 2560 x 2048 |
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical)<br>Vertical: 178° (Typical) |
| Screen brightness | 1150 cd/m² (typical) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| Power supply: | |
| Line voltage | DC 24 V |
| Current consumption | 5.0 A |
| Power consumption | < 100 W |
| Standby | ≤ 0.5 W |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch*1 DVI-D*1 DP*1 USB Upstream Port*2 USB Downstream Port*4 |

## C510S, CB5MP Color LCD monitors

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| Mechanical characteristics: | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1, IEC 60601-1-2<br>EN 60601-1, EN 60601-1-2<br>ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1<br>CAN/CSA-C22.2 NO. 60601-1:14 |
| Conformity | CCC, CE, FCC, TUV, CB, China energy |
| Dimension: | |
| With packing (W x H x D) | 483 x 321 x 627 mm |
| Weight: | |
| Gross weight | Approximate 12.6 ± 0.5 kg |
| Net weight | Approximate 9.1 ± 0.5 kg |

## G510S, MB5MP Monochrome LCD Monitors

| Panel characteristics: | |
|------------------------|-------------------------------------------------------------|
| Screen technology | 21.3", TFT, grayscale, LCD screen, anti-glare, hard coating |
| Active area (H x V) | 422.4 x 337.92 mm |
| Pixel pitch | 0.165 mm (H) x 0.165 mm (V) |

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| Resolution | 2560 x 2048 | |
|-----------------------------------|---------------------------------------------------------------------------------------------|--|
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) | |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical)<br>Vertical: 178° (Typical) | |
| Screen brightness | 3000 cd/m² (typical) | |
| Refresh rate | 50 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50,000 hours | |
| Response time (TR+TF) | 11 + 14 ms (typical) | |
| Power supply: | | |
| Line voltage | DC 24 V | |
| Current consumption | 5.0 A | |
| Power consumption | < 100 W | |
| Standby | ≤ 0.5 W | |
| Control and connection: | | |
| Front | 1 operation LED, 6 functional keys | |
| Back | ● Power switch*1<br>● DVI-D*1<br>● DP*1<br>● USB Upstream Port*2<br>● USB Downstream Port*4 | |
| Mechanical characteristics: | | |
| Housing components | Plastic | |
| Ventilation openings | Natural heat radiation | |
| Degree of protection | IP20 | |
| Climatic conditions: | | |
| Working temperature | 0°C - 40°C | |
| Working humidity | 15% - 85% Relative humidity, no condensation | |
| Transport and storage temperature | -20°C - 60°C | |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation | |
| Air pressure | 700hPa - 1060hPa | |
| Safety regulations : | | |
| | IEC 60601-1, IEC 60601-1-2 | |
| | EN 60601-1, EN 60601-1-2 | |
| Safety standards | ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1 | |
| | CAN/CSA-C22.2 NO. 60601-1:14 | |
| Conformity | CCC, CE, FCC, TUV, CB, China energy | |
| Dimension: | | |
| With packing (W x H x D) | 483 x 321 x 627 mm | |
| Weight : | | |
| Gross weight | Approximate 12.6 ± 0.5 kg | |
| Net weight | Approximate 9.1 ± 0.5 kg | |

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## C516S Color LCD monitor

| Panel characteristics: | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
| Active area(H x V) | 422.4 x 337.92 mm |
| Pixel pitch | 0.165 mm (H) x 0.165 mm (V) |
| Resolution | 2560 x 2048 |
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical) |
| | Vertical: 178° (Typical) |
| Screen brightness | 1150 cd/m² (typical) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| <b>Power supply:</b> | |
| Power connection | Adapter |
| Output | +24VDC, 5.0A |
| <b>Power consumption:</b> | |
| Normal Mode | 100W (Maximum) |
| Standby Mode | 0.5 W (Maximum) |
| <b>Control and connection :</b> | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch*1 DC Input*1 DVI-D*1 DP*2 DP-OUT*1 USB-A*1 USB Upstream Port*2 USB Downstream Port*4 |
| <b>Mechanical characteristics :</b> | |
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| <b>Climatic conditions :</b> | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| <b>Safety regulations :</b> | |
| Safety standards | IEC 60601-1, IEC 60601-1-2<br>EN 60601-1, EN 60601-1-2<br>ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1<br>CAN/CSA-C22.2 NO. 60601-1:14 |
| Conformity | CCC, CE, FCC, cTUVus, Energy Conservation<br>Certification |
| Dimension: | |
| With packing(W x H x D) | 483 x 321 x 627 mm |
| Weight: | |
| Gross weight | Approximate $13.3 \pm 0.5$ kg |
| Net weight | Approximate $9.3 \pm 0.5$ kg |

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510(k) Summary

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#### G516S Monochrome LCD Monitor

| Panel characteristics: | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Screen technology | 21.3", TFT, grayscale, LCD screen, anti-glare, hard coating | |
| Active area(H x V) | 422.4 x 337.92 mm | |
| Pixel pitch | 0.165 mm(H) x 0.165 mm(V) | |
| Resolution | 2560 x 2048 | |
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) | |
| Viewing angle(CR > 10) | Horizontal: 178°(Typical) | |
| | Vertical: 178°(Typical) | |
| Screen brightness | 3000 cd/m²(typical) | |
| Refresh rate | 50 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50,000 hours | |
| Response time(TR+TF) | 11 + 14 ms(typical) | |
| Power supply: | | |
| Power connection | Adapter | |
| Output | +24VDC, 5.0A | |
| Power consumption: | | |
| Normal Mode | 100W (Maximum) | |
| Standby Mode | 0.5 W (Maximum) | |
| Control and connection : | | |
| Front | 1 operation LED, 6 functional keys | |
| Back | Power switch*1 DC Input*1 DVI-D*1 DP*2 DP-OUT*1 USB-A*1 USB Upstream Port*2 USB Downstream Port*4 | |
| Mechanical characteristics : | | |
| Housing components | | Plastic |
| Ventilation openings | | Natural heat radiation |
| Degree of protection | | IP20 |
| Climatic conditions : | | |
| Working temperature | | 0°C - 40°C |
| Working humidity | | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | | -20°C - 60°C |
| Transport and storage humidity | | 10% - 90% Relative humidity, no condensation |
| Air pressure | | 700hPa - 1060hPa |
| Safety regulations : | | |
| Safety standards | | IEC 60601-1, IEC 60601-1-2<br>EN 60601-1, EN 60601-1-2 |
| | ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1<br>CAN/CSA-C22.2 NO. 60601-1:14 | |
| Conformity | CCC, CE, FCC, cTUVus, Energy Conservation<br>Certification | |
| Dimension: | | |
| With packing(W x H x D) | 483 x 321 x 627 mm | |
| Weight: | | |
| Gross weight | Approximate 13.3 ± 0.5 kg | |
| Net weight | Approximate 9.3 ± 0.5 kg | |

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#### 510(k) Summary

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

#### 8.1 Indication for use:

| ID | Comparison Item | Proposed Device<br>5MP Color LCD Monitors C510S, CB5MP,<br>C516S.<br>5MP Monochrome LCD Monitors G510S,<br>MB5MP, G516S. | Predicate Device<br>5MP Color LCD Monitor CL-S500,<br>5MP Monochrome LCD Monitor MS-S500 | | |
|------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1 | Indication for use | C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM. | CL-S500 and MS-S500 are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM. | | |
| ID | Comparison<br>Item | Proposed Device<br>5MP Color LCD Monitors<br>C510S, CB5MP | Predicate Device<br>5MP Color LCD Monitor<br>CL-S500 | Explanation of Differences | |
| 2 | Display Performance/Specifications | | | | |
| 2.1 | Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - | |
| 2.2 | Viewing angle (H, V) | CR>10<br>Horizontal: Typ.178<br>Vertical: Typ.178 | CR>50<br>Horizontal: Typ.178<br>Vertical: Typ.178 | Different screen provided by the<br>different manufacturer | |
| 2.3 | Resolution or<br>matrix size | 5MP(2560 x 2048) | 5MP(2048 X 2560) | - | |
| 2.4 | Aspect ratio | 5:4 | 4:5 | - | |
| 2.5 | Display area | Horizontal: 422.4mm<br>Vertical: 337.92mm | Horizontal: 337.92mm<br>Vertical: 422.4mm | - | |
| 2.6 | Pixel pitch | Horizontal: 0.165mm<br>Vertical: 0.165mm | Horizontal: 0.165mm<br>Vertical: 0.165mm | - | |
| 2.7 | Response time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - | |
| 2.8 | Maximum luminance | Min. 920cd/m²<br>Typ. 1,150cd/m² | Min. 920cd/m²<br>Typ. 1,150cd/m² | - | |
| 2.9 | DICOM calibrated<br>luminance | 450cd/m² | 500cd/m² | Difference complies the DICOM<br>3.14. | |
| 2.10 | Contrast ratio | Min. 1600:1<br>Typ. 2000:1 | Min. 1600:1<br>Typ. 2000:1 | - | |
| 2.11 | Backlighting | LED | LED | - | |
| 2.12 | Grayscale Tones | 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 (DisplayPort): 1.073<br>billion<br>1024 from a palette of 16,369<br>tones<br>8-bit(DVI): 16.77 million 256<br>from a palette of 16,369 tones | 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. | |
| 2.13 | Luminance<br>non-uniformity<br>compensation | - | Digital Uniformity Correction<br>System | Different design scheme | |
| 3 | Video Signals | | | | |
| 3.1 | Input video signals | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | - | |
| 3.2 | Scanning Frequency<br>(H, V) | Landscape:<br>Horizontal: 104.852KHz<br>Vertical: 50Hz | Portrait:<br>Horizontal: 129.1KHz<br>Vertical: 50Hz<br>Landscape:<br>Horizontal: 103.5KHz<br>Vertical: 50Hz | Different design scheme | |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - | |
| 4 | Power Related Specifications | | | | |
| 4.1 | Power Requirements | DC 24V, 5A | AC 100-240V, 50/60Hz | Difference between built-in<br>power supply and built-out<br>power supply | |
| 4.2 | Power Consumption /<br>Save Mode | 100W<br>Less than 0.5W | 95W<br>Less than 1W | Compared with the predicate<br>device, the proposed device<br>consumes more power in the<br>operating mode and less power<br>in the power saving mode. | |
| 4.3 | Power Management | VESA DPMS and EPA power<br>saving,<br>DisplayPort 1.2 | DVI DMPM,<br>DisplayPort 1.2a | Different design scheme | |
| 5 | Miscellaneous Features/Specifications | | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/<br>Calibration Feedback System | QA Medivisor/ Medivisor<br>NXF-CAL | Different design scheme | |
| 5.2 | Sensors | Built-in Front Sensor<br>Built-in Ambient Light Sensor<br>Built-in Backlight Sensor | Built-in Front Sensor<br>Built-in Ambient Light Sensor | Different design scheme | |
| 5.3 | USB Ports/Standard | 2 upstream,<br>4 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | | |
| 5.4 | Dimensions with<br>stand (W x H x D) | 360.5 x 513.49/613.49 x 224<br>mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to<br>the different panel size | |

## 8.2 Comparison table

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#### Table 2 General Comparison of C510S, CB5MP

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| ID | Comparison<br>Item | Proposed Device<br>5MP Monochrome LCD<br>Monitors G510S, MB5MP | Predicate Device<br>5MP Monochrome LCD<br>Monitor MS-S500 | Explanation of Differences |
|------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen Technology | TFT Monochrome LCD Panel<br>(IPS) | TFT Monochrome LCD Panel<br>(IPS) | - |
| 2.2 | Viewing angle (H, V) | CR>10<br>Horizontal: Typ.178<br>Vertical: Typ.178 | CR>50<br>Horizontal: Typ.178<br>Vertical: Typ.178 | Different screen provided by the<br>different manufacturer |
| 2.3 | Resolution or<br>matrix size | 5MP (2560 X 2048) | 5MP (2048 X 2560) | - |
| 2.4 | Aspect ratio | 5: 4 | 4:5 | - |
| 2.5 | Display Area | Horizontal: 422.4mm<br>Vertical: 337.92mm | Horizontal: 337.92mm<br>Vertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mm<br>Vertical: 0.165mm | Horizontal: 0.165mm<br>Vertical: 0.165mm | - |
| 2.7 | Response Time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 2,400cd/m²<br>Typ. 3,000cd/m² | Min. 2,400cd/m²<br>Typ. 3,000cd/m² | - |
| 2.9 | DICOM calibrated<br>luminance | 450cd/m² | 1,000cd/m² | Difference complies the DICOM<br>3.14. |
| 2.10 | Contrast ratio | Min. 1600:1<br>Typ. 2000:1 | Min. 1600:1<br>Typ. 2000:1 | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | 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 (DVI): 256 from a palette<br>of 16,369 tones | 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. |
| 2.13 | Luminance<br>non-uniformity<br>compensation | - | Digital Uniformity Correction<br>System | Different design scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video signals | DVI-D x1<br>DisplayPort x1 | DVI-D x1<br>DisplayPort x1 | - |
| 3.2 | Scanning Frequency<br>(H, V) | Landscape:<br>Horizontal: 104.852KHz<br>Vertical: 50Hz | Portrait:<br>Horizontal: 129.1KHz<br>Vertical: 50Hz<br>Landscape:<br>Horizontal: 103.5KHz<br>Vertical: 50Hz | Different design scheme |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 24V, 5.0A | AC 100-240V, 50/60Hz | Difference between built-in<br>power supply and built-out<br>power supply |
| 4.2 | Power Consumption /<br>Save Mode | 100W<br>Less than 0.5W | 80W<br>Less than 1W | Compared with the predicate<br>device, the proposed device<br>consumes more power in the<br>operating mode and less power<br>in the power saving mode. |
| 4.3 | Power Management | VESA DPMS and EPA power<br>saving,<br>DisplayPort 1.2 | DVI DMPM,<br>DisplayPort 1.2a | Different design scheme |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/<br>Calibration Feedback System | QA Medivisor/ Medivisor<br>NXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor<br>Built-in Ambient Light Sensor<br>Built-in backlight sensor | Built-in Front Sensor<br>Built-in Ambient Light Sensor | Different design scheme |
| 5.3 | USB Ports/Standard | 2 upstream,<br>4 downstream / Rev. 2.0 | 1 upstream,<br>2 downstream / Rev. 2.0 | -…