3MP COLOR LCD DISPLAY

K140108 · Shenzhen Beacon Display Technology Co., Ltd. · LLZ · Feb 14, 2014 · Radiology

Device Facts

• Record ID: K140108
• Device Name: 3MP COLOR LCD DISPLAY
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Story

The C32SP+/C32S+ 3MP Color LCD Display is a 21.3-inch medical-grade monitor designed for viewing digital medical images. It accepts video inputs via DVI-D or Display Port. The device features a built-in brightness stabilization circuit and an ambient light sensor to maintain consistent image quality. It supports both landscape and portrait orientations and includes an anti-reflection coated protective screen. The display is intended for use by trained medical practitioners in clinical environments to review and analyze diagnostic images. By providing stable, high-resolution (2048 x 1536) visualization, the device assists clinicians in the interpretation of medical imaging data, facilitating clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through technical specifications, including resolution, brightness, contrast ratio, and compliance with electrical and electromagnetic safety standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

21.3-inch TFT monochrome LCD screen; 2048 x 1536 native resolution; 1700 cd/m² brightness; 1400:1 contrast ratio; 0.2115mm pixel pitch; 176° viewing angle. Connectivity: DVI-D, Display Port, USB. Power: DC12V/7.0A. Features: built-in brightness stabilization circuit, ambient light sensor, anti-reflection coating. Operates in continuous mode. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images, excluding digital mammography, for review and analysis.

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

• Nio Color 3MP LED (K131295)

Submission Summary (Full Text)

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K140108
page 1 of 6

510(k) Submission

# 510(k) Summary

[As required by 21 CFR 807.92]

FEB 1 4 2014

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

December 24, 2013

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

| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd | |
|------------------|--------------------------------------------------------------------------------------------------------------|--|
| Address: | Room 201, Incubator Building, CASTD, High-tech South 1st<br>street, Nanshan District, Shenzhen 518057, China | |
| Contact Name: | Wu Qin | |
| Telephone No.: | [phone] | |
| Fax No.: | [phone] | |
| Email Address: | [e-mail] | |

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

(2)]

| Trade Name: | 3MP Color LCD Display | |
|-----------------------|-------------------------------------------------------|--|
| Common Name: | Display system, medical image workstation, and others | |
| Classification: | 892.2050 system, image processing, radiological | |
| Product code: | LLZ | |
| 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:

BARCO N.V., Nio Color 3MP LED has been cleared by FDA through 510(k) No.K131295 (Decision Date -May 29, 2013),

510(k) Summary

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

The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.

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

The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

| Panel | 21.3", TFT monochrome LCD screen, antiglare |
|--------------------------|--------------------------------------------------------------------------------------------------------------------|
| Brightness (typ.) | 1700 cd/m² |
| CR (typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | 0.2115mm |
| Native resolution | 2048 x 1536 |
| Display area | 433.152mm(H) x 324.864mm(V) |
| Compatible video signals | 640 x 480@60Hz (progressive)<br>2048x1536@60Hz(progressive) |
| Horizontal resolution | 2048 x 1536 |
| Bandwidth | 216MHz |
| Aspect ratio | 4:3 |
| Screen size | 21.3" real diagonal |
| Power | DC12V/7.0A |
| Power consumption | Max. 80 W |
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (single) |
| Plug and play | VESA DDC 2B |
| Dimension | 369.0mm (W) x 482.6mm (H) x 63.6mm (D) (without Stand )<br>369.0 mm (W) x 626.6 mm (H) x 234.8mm (D) (with Stand ) |

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

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| Weight | 6.5kg (without Stand) |
|-------------------------------------------|-----------------------------------------------|
| | 9.5kg (with Stand) |
| Operating<br>temperature and<br>humidity: | Temperature: 0°C ~ 40°C<br>Humidity: 15%~85% |
| Storage<br>temperature and<br>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:

#### Table 1 Intended Use Comparison

| ID | Comparison Item | Proposed Device<br>C32SP+/C32S+ | Predicate Device<br>Nio Color 3MP LED |
|----|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended<br>Use | The C32SP+/C32S+ 3MP Color<br>LCD Display is intended to be<br>used in displaying and viewing<br>digital images (excluding digital<br>mammography) for review and<br>analysis by trained medical<br>practitioners. | "Nio Color 3MP LED" is<br>intended to be used as a tool in<br>displaying and viewing digital<br>images (excluding digital<br>mammography) for review and<br>analysis by trained medical<br>practitioners. |

#### 8.2 Comparison table

#### Table 2 General Comparison

| ID | Comparison<br>Item | Proposed Device<br>C32SP+/C32S+ | Predicate Device<br>Nio Color 3MP LED |
|-------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Performance | | |
| 2.1 | Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| 2.2 | Pixel Pitch | 0.2115 mm | 0.2115 mm |
| 2.3 | Available Cabinet<br>Colors | Black | Black |
| 2.4 | Native Resolutions | 2048 x1536 | 2048 x1536 |
| 2.5 | Brightness | 1700 cd/m2 | 1700 cd/m2 |
| 2.6 | Contrast Ratio | 1400:1 | 1300:1 |
| 2.7 | Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| 2.8 | Active Display Size | 433.152mm x324.864mm | 433.2mm x324.9mm |
| 3 | Physical Specifications | | |
| 3.1 | Dimensions<br>(Wx Hx D) | 369.0mm (W) x 482.6mm (H) | 375mm x 488mm x 84mm<br>(without Stand) |
| ID | Comparison Item | Proposed Device<br>C32SP+/C32S+ | Predicate Device<br>Nio Color 3MP LED |
| | | x 63.6mm (D) (without Stand) | Portrait:<br>375mm x 620~520mm<br>x 235mm |
| | | 369.0 mm (W) x 626.6 mm (H)<br>x 234.8mm (D) (with Stand) | Landscape:<br>488mm x 563~463mm<br>x 250mm<br>(with Stand) |
| Temperature | | | |
| 3.2 | Operating | 0°C ~ 40°C | 0°C ~ 40°C |
| 3.3 | Transport/ Storage | -20°C ~ 60°C | -20°C ~ 60°C |
| Relative humidity | | | |
| 3.4 | Operating | 15% ~85% | 8% ~80%(non-condensing) |
| 3.5 | Transport/ Storage | 10% ~90% | 5% ~95% |
| 4 | Power Supply | | |
| 4.1 | PowerCapacity | <80W | <40W |
| 4.2 | Input Voltage | DC12V/7.0A | 100~240v |
| 5 | Human factors (operation characteristic) | | |
| 5.1 | Usability | Button operation,<br>LED indicator | Button operation,<br>LED indicator |
| 5.2 | Mode of operation | Continuous operation | Continuous operation |
| 6 | Biocompatibility | | |
| 6.1 | Evaluation | The proposed device does not<br>contain any components that<br>come into direct or indirect<br>contact with patients, so the<br>evaluation doesn't be needed. | The proposed device does<br>not contain any components<br>that come into direct or<br>indirect contact with patients,<br>so the evaluation doesn't be<br>needed. |
| 7 | Sterility | | |
| 7.1 | Sterilization | The proposed device does not<br>need sterilization. | The proposed device does<br>not need sterilization. |
| 8 | Electrical & Mechanical safety& Thermal safety | | |
| 8.1 | Type of protection<br>against electric<br>shock | Class I | Class I |
| 8.2 | Degree of protection<br>against harmful<br>ingress of liquid | Ordinary equipment. | Ordinary equipment. |
| 8.3 | Evaluation | The electrical, mechanical and<br>thermal safety evaluation is<br>conducted as per the<br>requirements of the standard | The electrical, mechanical<br>and thermal safety evaluation<br>is conducted as per the<br>requirements of the standard |
| ID | Comparison<br>Item | Proposed Device<br>C32SP+/C32S+ | Predicate Device<br>Nio Color 3MP LED |
| | | IEC 60601-1. | IEC 60601-1. |
| 9 | Electromagnetic Compatibility | | |
| 9.1 | EMC Evaluation | Complying with<br>IEC 60601-1-2 | Complying with<br>IEC 60601-1-2 |

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K140108
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510(k) Submission

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K140108
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510(k) Submission

#### 8.4 Discussion of Differences:

It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).

Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images(excluding digital mammography) for review and analysis by trained medical practitioners. So the SE is not affected.

Review of ID 2 - Performance, except the item as below, it is the same, so the SE is not affected.

- 1. Contrast Ratio, The proposed device is 1400:1 and the predicate device is 1300:1, but the 1400:1 is better than 1300:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected

Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

Review of ID 5 - Human factors, both are the same, so the SE is not affected.

Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.

Review of ID 7 - Sterility, both are the same, so the SE is not affected.

Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.

Review of ID 9 - EMC, both are the same, so the SE is not affected.

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

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and

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K140108
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510(k) Submission

based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd concludes that C32SP+/C32S+ 3MP Color LCD display is substantially equivalent to predicate devices with regard to safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is written around the upper portion of the circle.

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

#### February 14, 2014

Shenzhen Beacon Display Technology Co., Ltd. % Ms. Wu Qin Room 201, Incubator Building, CASTD High-tech South 1st Street Shenzhen, Guangdong 518057 CHINA :

Re: K140108

Trade/Device Name: 3MP Color LCD Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 26, 2013 Received: January 15, 2014

Dear Ms. Qin:

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 (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.

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Page 2-Ms. Qin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K140108

Device Name: C32SP+/C32S+ 3MP Color LCD Display

Indications for Use:

The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Sm.n.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K140108

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