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 Description

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.

AI/ML Overview

The provided document describes a 510(k) submission for a 3MP Color LCD Display (C32SP+/C32S+) for medical viewing. The submission focuses on demonstrating substantial equivalence to a predicate device, the BARCO Nio Color 3MP LED.

Acceptance Criteria and Device Performance:

The "acceptance criteria" in this context are not explicitly stated as quantitative thresholds for a medical device's performance in a diagnostic study. Instead, for this type of device (a medical display), "acceptance criteria" are typically related to meeting established technical and safety standards, and demonstrating performance comparable to a cleared predicate device.

The document provides a comparison table (Table 2 General Comparison) that serves as the basis for demonstrating substantial equivalence. The "reported device performance" refers to the specifications of the proposed device.

Comparison Item	Acceptance Criteria (based on predicate)	Reported Device Performance (Proposed Device C32SP+/C32S+)
Panel Size and Type	21.3", TFT LCD display	21.3", TFT LCD display
Pixel Pitch	0.2115 mm	0.2115 mm
Available Cabinet Colors	Black	Black
Native Resolutions	2048 x 1536	2048 x 1536
Brightness	1700 cd/m²	1700 cd/m²
Contrast Ratio	1300:1	1400:1
Network Interface	USB(1 Up, 2 Downstream)	USB(1 Up, 2 Downstream)
Active Display Size	433.2mm x 324.9mm	433.152mm x 324.864mm
Dimensions (without Stand)	375mm x 488mm x 84mm	369.0mm (W) x 482.6mm (H) x 63.6mm (D)
Operating Temperature	0°C ~ 40°C	0°C ~ 40°C
Transport/Storage Temperature	-20°C ~ 60°C	-20°C ~ 60°C
Operating Relative Humidity	8% ~ 80% (non-condensing)	15% ~ 85%
Transport/Storage Relative Humidity	5% ~ 95%	10% ~ 90%
Power Capacity	<40W	<80W
Input Voltage	100~240v	DC12V/7.0A
Usability	Button operation, LED indicator	Button operation, LED indicator
Mode of operation	Continuous operation	Continuous operation
Type of protection against electric shock	Class I	Class I
Degree of protection against harmful ingress of liquid	Ordinary equipment	Ordinary equipment
EMC Evaluation	Complying with IEC 60601-1-2	Complying with IEC 60601-1-2

Study Information (Device K140108 - 3MP Color LCD Display)

This submission is for a medical display, not a diagnostic algorithm, so the concept of a "study" to prove performance against clinical ground truth or human reader performance is not applicable in the same way it would be for an AI-powered diagnostic device. Instead, the "study" is a technical comparison against a predicate device and adherence to relevant standards.

Sample size used for the test set and the data provenance: Not applicable. This is a hardware comparison based on technical specifications and compliance with standards. There is no "test set" of medical images or patient data in the context of diagnostic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a display device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established technical specifications and performance of a legally marketed predicate device, and compliance with recognized safety and performance standards (e.g., 21 CFR 1020.33, IEC 60601-1, IEC 60601-1-2).
The sample size for the training set: Not applicable. There is no training set for a display device.
How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a technical and regulatory comparison against a predicate device (BARCO Nio Color 3MP LED) and adherence to recognized standards.

Methodology: The manufacturer conducted a direct comparison of the proposed device's technical specifications and intended use against those of the predicate device. They also ensured compliance with relevant safety and performance standards.
Key Findings:
- Intended Use: The intended use is identical to the predicate device: "displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners."
- Performance (Technical Specifications): Most technical parameters (Panel Size, Pixel Pitch, Native Resolutions, Brightness, Network Interface, Active Display Size, Operating/Storage Temperature ranges, Usability, Mode of Operation, Electrical/Mechanical Safety, EMC) were found to be either identical or comparable to the predicate.
- Differences and Justification for Substantial Equivalence:
  - Contrast Ratio: The proposed device has a slightly higher contrast ratio (1400:1) than the predicate (1300:1), which the manufacturer argued is "better" and does not negatively affect safety and effectiveness.
  - Dimensions, Relative Humidity, Power Capacity, Input Voltage: While some numerical differences exist, the manufacturer states these are "comparable" or comply with relevant general safety standards (IEC 60601-1, IEC 60601-1-2), and thus do not affect safety or effectiveness.
Conclusion: The manufacturer concluded that the C32SP+/C32S+ 3MP Color LCD display is substantially equivalent to the predicate device (BARCO Nio Color 3MP LED) with regard to safety and effectiveness, based on the comparative analysis and compliance with standards. The FDA subsequently cleared the device, confirming this substantial equivalence.

Summary

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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 1ststreet, Nanshan District, Shenzhen 518057, China
Contact Name:	Wu Qin
Telephone No.:	+86 755 26995355
Fax No.:	+86 755 26995755
Email Address:	wuqin@beacon-display.cn

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)]

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)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 )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)
Operatingtemperature andhumidity:	Temperature: 0°C ~ 40°CHumidity: 15%~85%
Storagetemperature andhumidity:	Temperature: -20°C ~ 60°CHumidity: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 DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
1	IntendedUse	The C32SP+/C32S+ 3MP ColorLCD Display is intended to beused in displaying and viewingdigital images (excluding digitalmammography) for review andanalysis by trained medicalpractitioners.	"Nio Color 3MP LED" isintended to be used as a tool indisplaying and viewing digitalimages (excluding digitalmammography) for review andanalysis by trained medicalpractitioners.

8.2 Comparison table

Table 2 General Comparison

ID	ComparisonItem	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio 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 CabinetColors	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(Wx Hx D)	369.0mm (W) x 482.6mm (H)	375mm x 488mm x 84mm(without Stand)
ID	Comparison Item	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
		x 63.6mm (D) (without Stand)	Portrait:375mm x 620~520mmx 235mm
		369.0 mm (W) x 626.6 mm (H)x 234.8mm (D) (with Stand)	Landscape:488mm x 563~463mmx 250mm(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,LED indicator	Button operation,LED indicator
5.2	Mode of operation	Continuous operation	Continuous operation
6	Biocompatibility
6.1	Evaluation	The proposed device does notcontain any components thatcome into direct or indirectcontact with patients, so theevaluation doesn't be needed.	The proposed device doesnot contain any componentsthat come into direct orindirect contact with patients,so the evaluation doesn't beneeded.
7	Sterility
7.1	Sterilization	The proposed device does notneed sterilization.	The proposed device doesnot need sterilization.
8	Electrical & Mechanical safety& Thermal safety
8.1	Type of protectionagainst electricshock	Class I	Class I
8.2	Degree of protectionagainst harmfulingress of liquid	Ordinary equipment.	Ordinary equipment.
8.3	Evaluation	The electrical, mechanical andthermal safety evaluation isconducted as per therequirements of the standard	The electrical, mechanicaland thermal safety evaluationis conducted as per therequirements of the standard
ID	ComparisonItem	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
		IEC 60601-1.	IEC 60601-1.
9	Electromagnetic Compatibility
9.1	EMC Evaluation	Complying withIEC 60601-1-2	Complying withIEC 60601-1-2

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K140108
Page 4 of 16
510(k) Submission

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K140108
Page 5 of 6

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
Page 6 of 6
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

Page 1 of

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).