Who is the manufacturer of LCD Monitors C310S, G310S, C316S, G316S, C616W?

Shenzhen Beacon Display Technology Co., Ltd. filed the 510(k) submission for LCD Monitors C310S, G310S, C316S, G316S, C616W (K243031).

What is the FDA product code for LCD Monitors C310S, G310S, C316S, G316S, C616W?

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

What is the regulatory pathway for LCD Monitors C310S, G310S, C316S, G316S, C616W?

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

What are the predicate devices for LCD Monitors C310S, G310S, C316S, G316S, C616W?

LCD Monitors C310S, G310S, G316S, G316S, C616W (K240310).

Who can help prepare an FDA 510(k) submission like LCD Monitors C310S, G310S, C316S, G316S, C616W?

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.

LCD Monitors C310S, G310S, C316S, G316S, C616W

K243031 · Shenzhen Beacon Display Technology Co., Ltd. · PGY · Oct 25, 2024 · Radiology

Device Facts

Record ID	K243031
Device Name	LCD Monitors C310S, G310S, C316S, G316S, C616W
Applicant	Shenzhen Beacon Display Technology Co., Ltd.
Product Code	PGY · Radiology
Decision Date	Oct 25, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended Use

C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

Device Story

LCD monitors (C310S, G310S, C316S, G316S, C616W) provide high-definition output for general radiography and diagnostic imaging. Devices receive video input via DVI-D or DisplayPort from medical imaging systems. Integrated LED backlight panels and brightness stabilization circuits ensure consistent luminance. Anti-glare screens and sensors (backlight, front, ambient, presence, gravity) optimize image quality. Operated by trained medical practitioners in clinical settings, the monitors display images for review, analysis, and diagnosis. The DBI Calibration Feedback System (CFS) software manages display calibration to meet DICOM Part 3.14 standards. Output allows clinicians to view high-precision medical images, facilitating accurate diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Performance verified against FDA guidance 'Display Devices for Diagnostic Radiology' including spatial resolution (MTF), pixel defects, artifacts, temporal response, luminance, DICOM GSDF conformance, and color tracking. All tests passed.

Technological Characteristics

TFT LCD panels (IPS) with LED backlighting. Resolutions: 1536x2048 (3MP) or 3280x2080 (6MP). Connectivity: DVI-D, DisplayPort. Sensors: Backlight, front, ambient, presence, gravity. Calibration: DBI Calibration Feedback System. Software: Embedded firmware and calibration tools (Basic Documentation Level). Compliance: DICOM Part 3.14, IEC 62304.

Indications for Use

Indicated for trained medical practitioners to display radiological images (C310S, C316S, C616W) or digital images for X-ray/MRI diagnosis (G310S, G316S). Not for mammography.

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

LCD Monitors C310S, G310S, G316S, G316S, C616W (K240310)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Shenzhen Beacon Display Technology Co.,Ltd. Li Yafei Official Correspondent 15F, Building 6, Hengda Shishang Huigu(East), Fulong Road, Dalang Subdistrict, Longhua Shenzhen, Guangdong 518109 China October 25, 2024 Re: K243031 Trade/Device Name: LCD Monitors C310S. C310S. C316S. G316S. C616W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: September 26, 2024 Received: September 27, 2024 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/cdrb/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. {1}------------------------------------------------ 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). 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 OS 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 {2}------------------------------------------------ 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, 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 Enclosure {3}------------------------------------------------ #### Indications for Use Submission Number (if known) K243031 Device Name LCD Monitors C310S, G310S, C316S, G316S, C616W Indications for Use (Describe) C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. G310S and G316S are intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems. 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) #### 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." {4}------------------------------------------------ K243031 # 510 (k) Summary {5}------------------------------------------------ ## 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR807.92 (a) (1)] Sep 23, 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 Subdistrict, Longhua, Shenzhen, 518109 China | | Contact Name: | Li Yafei | | Telephone No.: | +86-024-88087610 | | Fax No.: | +86-024-88087629 | | Email Address: | livf@beacon-display.cn | ## 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)] | ● Trade Name/Model: | 3MP Color LCD Monitors C310S, C316S; 3MP Monochrome LCD Monitors G310S, G316S; 6MP Color LCD Monitor C616W. | |-------------------------|-------------------------------------------------------------------------------------------------------------------| | ● Common Name: | LCD Monitors C310S, G310S, C316S, G316S, C616W | | ● 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)] {6}------------------------------------------------ The identified predicate within this submission is as follows: Shenzhen Beacon Display Technology Co., Ltd., LCD Monitors C310S, G310S, G316S, G316S, C616W has been cleared by FDA through 510(k) No. K240310 (Decision Date - 03/29/2024). ## 5. Description of the Device [21 CFR 807.92(a) (4)] 3MP LCD Monitors C310S, G310S, C316S, G316S 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 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, 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. 6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography. This product has 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 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets 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. C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle. G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle. C310S and G310S have the same main board and design principle. C316S and G316S have the same main board and design principle. ### 6. Indications for use C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. G310S and G316S are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital {7}------------------------------------------------ mammography systems. ## 7. Technological Characteristics (Substantial Equivalence) [21 CFR 807.92(a)(6)] | ID | Comparison Item | Proposed Device | Predicate Device K240310 | Explanation of Differences | |-----------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | | | C310S | C310S | | | 1.Display Performance/Specifications | | | | | | 1.1 | Display technology | Color (IPS) | Color (IPS) | same | | 1.2 | Screen size | 54.1cm/21.3" Aspect ratio:3:4 | 54.1cm/21.3" Aspect ratio:3:4 | same | | 1.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | same | | 1.4 | Native resolution | 1536 x 2048 | 1536 x 2048 | same | | 1.5 | Viewable image size (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same | | 1.6 | Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | same | | 1.7 | Response time (typical) | 25 ms (on / off) | 25 ms (on / off) | same | | 1.8 | Brightness (typical) | 1100cd/m² | 1100cd/m² | same | | 1.9 | Recommended brightness | 450 cd/m² | 450 cd/m² | same | | 1.10 | Contrast ratio (typical) | 2000:1 | 2000:1 | same | | 1.11 | Backlight type | LED | LED | same | | 1.12 | Display colors | 10-bit (DisplayPort): 1.073 billion 1024 from a palette of 16,384 tones 8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | 10-bit (DisplayPort): 1.073 billion 1024 from a palette of 16,384 tones 8-bit(DVI): 16.77 million 256 from a palette of 16,384 tones | same | | 2.Video Signals | | | | | | 2.1 | Input video signals | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 | same | | 2.2 | Digital Scanning Frequency (H, V) | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | same | | 2.3 | Video bandwidth | DVI: 214.25 MHz DisplayPort: 214.25 MHz | DVI: 214.25 MHz DisplayPort: 214.25 MHz | same | | 3.Power Related Specifications | | | | | | 3.1 | Power Requirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same | | 3.2 | Maximum power consumption | 100 W | 100 W | same | | 3.3 | Power save mode | Less than or equal to 0.5 W | Less than or equal to 0.5 W | same | | 3.4 | Power Management | VESA DPMS and EPA power saving management, DisplayPort 1.2 | VESA DPMS and EPA power saving management, DisplayPort 1.2 | same | | 4.Miscellaneous Features/Specifications | | | | | | 4.1 | Calibration Tool | Beacon Monitor Manage/ Calibration Feedback System | Beacon Monitor Manage | Different | | 4.2 | Sensors | Backlight sensor Integrated front sensor Ambient sensor | Backlight sensor Integrated front sensor Ambient sensor | same | | 4.3 | USB Ports | 2 USB Upstream Port 4 USB Downstream Port | 2 USB Upstream Port 4 USB Downstream Port | same | | 4.4 | Brightness stabilization | Yes | Yes | same | | 4.5 | Net weight | $8.2 \pm 0.5$ kg | $8.2 \pm 0.5$ kg | same | | 4.6 | Dimensions w/o stand (W x H x D) | 342.5 x 520.26 ~ 620.26 x 224 | 342.5 x 520.26 ~ 620.26 x 224 | same | | 5. Indications for Use | | | | | | 5.1 | Indications for Use | This product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. This product is not intended for mammography. | This product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. This product is not intended for mammography. | same | #### Table 1 General Comparison of C310S {8}------------------------------------------------ {9}------------------------------------------------ #### Table 2 General Comparison of C316S | ID | Comparison Item | Proposed Device | Predicate Device K240310 | Explanation of Differences | |------|--------------------------------------|----------------------------------|----------------------------------|-------------------------------| | | | C316S | C316S | | | | 1.Display Performance/Specifications | | | | | 1.1 | Display technology | Color (IPS) | Color (IPS) | same | | 1.2 | Screen size | 54.1cm/21.3" Aspect ratio:3:4 | 54.1cm/21.3" Aspect ratio:3:4 | same | | 1.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | same | | 1.4 | Native resolution | 1536 x 2048 | 1536 x 2048 | same | | 1.5 | Viewable image size (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same | | 1.6 | Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | same | | 1.7 | Response time (typical) | 25 ms (on / off) | 25 ms (on / off) | same | | 1.8 | Brightness (typical) | 1100cd/m² | 1100cd/m² | same | | 1.9 | Recommended brightness | 450 cd/m² | 450 cd/m² | same | | 1.10 | Contrast ratio (typical) | 2000:1 | 2000:1 | same | | 1.11 | Backlight type | LED | LED | same | {10}------------------------------------------------ | | | 10-bit (DisplayPort): | 10-bit (DisplayPort): | | | | | |------|-----------------------------------------|---------------------------------------|--------------------------------|-----------|--|--|--| | | | 1.073 billion | 1.073 billion | | | | | | | | 1024 from a palette of | 1024 from a palette of | | | | | | 1.12 | Display colors | 16,384 tones | 16,384 tones | | | | | | | | 8-bit(DVI): 16.77 | 8-bit(DVI): 16.77 | same | | | | | | | million 256 from a | million 256 from a | | | | | | | | palette of 16,384 | palette of 16,384 | | | | | | | | tones | tones | | | | | | | 2.Video Signals | | | | | | | | 2.1 | Input video | DVI-D (dual link) x 1, | DVI-D (dual link) x 1, | | | | | | | signals | DisplayPort x 2 | DisplayPort x 2 | same | | | | | | | Landscape: | Landscape: | | | | | | 2.2 | Digital Scanning | Horizontal: | Horizontal: | | | | | | | Frequency (H, V) | 126.327KHz | 126.327KHz | same | | | | | | | Vertical: 59.956Hz | Vertical: 59.956Hz | | | | | | 2.3 | Video | DVI: 216 MHz | DVI: 216 MHz | | | | | | | bandwidth | DisplayPort: 216 MHz | DisplayPort: 216 MHz | same | | | | | | | | 3.Power Related Specifications | | | | | | 3.1 | Power | DC 24V/ 5.0A | DC 24V/ 5.0A | same | | | | | | Requirements | | | | | | | | 3.2 | Maximum power | 100 W | 100 W | same | | | | | | consumption Power save | Less than or equal to | Less than or equal to | | | | | | 3.3 | mode | 0.5 W | 0.5 W | same | | | | | | | VESA DPMS and | VESA DPMS and | | | | | | | Power | EPA power saving | EPA power saving | | | | | | 3.4 | Management | | | same | | | | | | | management, | management, | | | | | | | | DisplayPort 1.2 | DisplayPort 1.2 | | | | | | | 4.Miscellaneous Features/Specifications | | | | | | | | | Calibration Tool | Beacon Monitor Manage/ Calibration | Beacon Monitor | | | | | | 4.1 | | Feedback System | Manage | Different | | | | | | | Backlight sensor | Backlight sensor | | | | | | | | Integrated front sensor | Integrated front sensor | | | | | | 4.2 | Sensors | Ambient sensor | Ambient sensor | | | | | | | | Presence sensor | Presence sensor | same | | | | | | | Gravity sensor | Gravity sensor | | | | | | | | 1 USB-A | 1 USB-A | | | | | | 4.3 | | 2 USB Upstream Port | 2 USB Upstream Port | | | | | | | USB Ports | 4 USB Downstream | 4 USB Downstream | same | | | | | | | Port | Port | | | | | {11}------------------------------------------------ | 4.4 | Brightness stabilization | Yes | Yes | same | |-----|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | 4.5 | Net weight | $8.6 \pm 0.5$ kg | $8.6 \pm 0.5$ kg | same | | 4.6 | Dimensions w/o stand (W x H x D) | 342.5 x 520.26 ~ 620.26 x 224 | 342.5 x 520.26 ~ 620.26 x 224 | same | | | 5. Indications for Use | | | | | 5.1 | Indications for Use | This product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. This product is not intended for mammography. | This product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. This product is not intended for mammography. | same | #### Table 3 General Comparison of G310S | ID | Comparison Item | Proposed Device | Predicate Device K240310 | Explanation of Differences | |-----------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | | | G310S | G310S | | | | | 1.Display Performance/Specifications | | | | 1.1 | Display technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | same | | 1.2 | Screen size | 54.1 cm / 21.3" (541 mm diagonal) | 54.1 cm / 21.3" (541 mm diagonal) | same | | 1.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | same | | 1.4 | Native resolution | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | same | | 1.5 | Viewable image size (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same | | 1.6 | Pixel pitch | 0.2115 mm (H) x 0.2115 mm (V) | 0.2115 mm (H) x 0.2115 mm (V) | same | | 1.7 | Response time (typical) | 25 ms (On/Off) | 25 ms (On/Off) | same | | 1.8 | Brightness (typical) | 2500 cd/m² | 2500 cd/m² | same | | 1.9 | Recommended brightness | 450 cd/m² | 450 cd/m² | same | | | | | | | | 1.10 | Contrast ratio (typical) | 2500:1 | 2500:1 | same | | 1.11 | Backlight type | LED | LED | same | | 1.12 | Grayscale Tones | 10-bit (DisplayPort): 1,024 from a palette of 16,384 tones 8-bit (DVI): 256 from a palette of 16,384 tones | 10-bit (DisplayPort): 1,024 from a palette of 16,384 tones 8-bit (DVI): 256 from a palette of 16,384 tones | same | | 2.Video Signals | | | | | | 2.1 | Input video signals | DVI-D (dual link) x 1 DisplayPort x 1 | DVI-D (dual link) x 1 DisplayPort x 1 | same | | 2.2 | Digital Scanning Frequency (H, V) | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | same | | 2.3 | Dot Clock | DVI: 214.25 MHz DisplayPort: 214.25 MHz | DVI: 214.25 MHz DisplayPort: 214.25 MHz | same | | 3.Power Related Specifications | | | | | | 3.1 | Power Requirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same | | 3.2 | Maximum power consumption | 60 W | 60 W | same | | 3.3 | Power save mode | Less than or equal to 0.5 W | Less than or equal to 0.5 W | same | | 3.4 | Power Management | VESA DPMS and EPA power saving management, DisplayPort 1.2 | VESA DPMS and EPA power saving management, DisplayPort 1.2 | same | | 4.Miscellaneous Features/Specifications | | | | | | 4.1 | Calibration Tool | Beacon Monitor Manage/ Calibration Feedback System | Beacon Monitor Manage | Different | | 4.2 | Sensors | Backlight sensor Integrated front sensor Ambient sensor | Backlight sensor Integrated front sensor Ambient sensor | same | | 4.3 | USB Ports | 2 USB Upstream Port 4 USB Downstream Port/ Rev. 2.0 | 2 USB Upstream Port 4 USB Downstream Port/ Rev. 2.0 | same | | 4.4 | Brightness stabilization | Yes | Yes | same | | 4.5 | Net weight | 8.2 ± 0.5 | 8.2 ± 0.5 | same | | 4.6 | Dimensions w/o stand (W x H x D) | 342.5 x 520.26 ~ 620.26 x 224 | 342.5 x 520.26 ~ 620.26 x 224 | same | | | 5. Indications for Use | | | | | 5.1 | Indications for Use | This product is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. This product is not specified for digital mammography systems. | This product is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. This product is not specified for digital mammography systems. | same | {12}------------------------------------------------ {13}------------------------------------------------ 510(k) Submission #### Table 4 General Comparison of G316S | ID | Comparison Item | Proposed Device G316S | Predicate Device K240310 G316S | Explanation of Differences | |-----------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | 1.Display Performance/Specifications | | | | | | 1.1 | Display technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | same | | 1.2 | Screen size | 54.1 cm / 21.3" (541 mm diagonal) | 54.1 cm / 21.3" (541 mm diagonal) | same | | 1.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | same | | 1.4 | Native resolution | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | same | | 1.5 | Viewable image size (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same | | 1.6 | Pixel pitch | 0.2115 mm (H) x 0.2115 mm (V) | 0.2115 mm (H) x 0.2115 mm (V) | same | | 1.7 | Response time (typical) | 25 ms (On/Off) | 25 ms (On/Off) | same | | 1.8 | Brightness (typical) | 2500 cd/m² | 2500 cd/m² | same | | 1.9 | Recommended brightness | 450 cd/m² | 450 cd/m² | same | | 1.10 | Contrast ratio (typical) | 2500:1 | 2500:1 | same | | 1.11 | Backlight type | LED | LED | same | | | | | | | | 1.12 | Grayscale Tones | 10-bit (DisplayPort): 1,024 from a palette of 16,384 tones | 10-bit (DisplayPort): 1,024 from a palette of 16,384 tones | same | | | | 8-bit (DVI): 256 from a palette of 16,384 tones | 8-bit (DVI): 256 from a palette of 16,384 tones | | | | | | | | | 2.Video Signals | | | | | | 2.1 | Input video signals | DVI-D (dual link) x 1 DisplayPort x 1 | DVI-D (dual link) x 1 DisplayPort x 1 | same | | 2.2 | Digital Scanning Frequency (H, V) | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | Landscape: Horizontal: 126.327KHz Vertical: 59.956Hz | same | | 2.3 | Dot Clock | DVI: 216 MHz DisplayPort: 216 MHz | DVI: 216 MHz DisplayPort: 216 MHz | same | | 3.Power Related Specifications | | | | | | 3.1 | Power Requirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same | | 3.2 | Maximum power consumption | 60 W | 60 W | same | | 3.3 | Power save mode | Less than or equal to 0.5 W | Less than or equal to 0.5 W | same | | 3.4 | Power Management | VESA DPMS and EPA power saving management, DisplayPort 1.2 | VESA DPMS and EPA power saving management, DisplayPort 1.2 | same | | 4.Miscellaneous Features/Specifications | | |…