(28 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and calibration of the monitors for displaying medical images, with no mention of AI or ML for image analysis or processing.
No
The devices are monitors used for displaying radiological images for diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners" and "intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners." This direct mention of "diagnosis" clearly identifies the device as a diagnostic one.
No
The device description explicitly states that the devices are "TFT LCD monitors" and describes their physical characteristics and components (LCD panel, main board, LED backlight panel, anti-glare screen). This indicates they are hardware devices, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." This involves displaying images generated from medical imaging modalities (like X-ray and MRI) that are already acquired from the patient.
- Device Description: The device is described as an LCD monitor specifically designed for displaying high-definition medical images. Its features are related to image display quality (resolution, brightness stabilization, anti-glare).
- Lack of In Vitro Activity: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, disease, or congenital abnormality. This device does not interact with or analyze biological specimens.
- Focus on Image Display: The entire description and performance testing focus on the quality and characteristics of the image display itself, not on analyzing or processing biological samples.
Therefore, the device falls under the category of a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Test Performance Test
Physical Laboratory Test items suggested in the FDA guidance "Display Devices for Diagnostic Radiology" were tested on the display embedded software using DBI Calibration Feedback System on C310S, G310S, C316S, G316S, C616W.
- 1. Spatial resolution: Measurement of spatial resolution expressed as modulation transfer function (MTF) - PASS
- 2. Pixel defects: The maximum number allowed for each type of pixel defects/faults - PASS
- 3. Artifacts: Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline - PASS
- 4. Temporal response: Measure the temporal response using the typical data provided by the panel manufacturer - PASS
- 5. Luminance (maximum, minimum, achievable, and recommended): Meausure the maximum, minimum, achievable, and recommended luminance - PASS
- 6. Conformance to a grayscale-to luminance function: Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline) - PASS
- 7. Color tracking (primary colors and color gamut): Measurement of Color tracking (primary colors and color gamut) - PASS
All display characteristics of the display embedded software have met the pre-determined criteria. Therefore, the test results showed that C310S, G310S, C316S, C616W are with display characteristics equivalent to those of the predicate devices.
No animal or clinical testing is needed for C310S, C316S, G316S, C616W.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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)
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
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 |
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| 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 | | | | |
| 4.1 | Calibration Tool | Beacon Monitor
Manage/ Calibration
Feedback System | Beacon Monitor
Manage | Different |
| 4.2 | Sensors | Backlight sensor
Integrated front sensor
Ambient sensor
Presence sensor
Gravity sensor | Backlight sensor
Integrated front sensor
Ambient sensor
Presence sensor
Gravity sensor | same |
| 4.3 | USB Ports | 1 USB-A
2 USB Upstream Port
4 USB Downstream
Port/ Rev. 2.0 | 1 USB-A
2 USB Upstream Port
4 USB Downstream
Port/ Rev. 2.0 | same |
| 4.4 | Brightness
stabilization | Yes | Yes | same |
| 4.5 | Net weight | 8.6 ± 0.5 | 8.6 ± 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 |
14
15
Table 5 General Comparison of C616W
| ID | Comparison
Item | Proposed Device | Predicate Device
K240310 | Explanation of
Differences |
|------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | | C616W | C616W | |
| | 1.Display Performance/Specifications | | | |
| 1.1 | Display
technology | TFT Color LCD Panel
(IPS) | TFT Color LCD Panel
(IPS) | same |
| 1.2 | Screen size | 30" (Aspect Ratio
16:10) | 30" (Aspect Ratio
16:10) | same |
| 1.3 | Viewing angle
(H/V) | H: 178°; V: 178° | H: 178°; V: 178° | same |
| 1.4 | Native
resolution | 3280 x 2080 | 3280 x 2080 | same |
| 1.5 | Viewable image
size (H x V) | 645.504 x 409.344 mm | 645.504 x 409.344 mm | same |
| 1.6 | Pixel pitch | 0.197 mm (H) x 0.197
mm (V) | 0.197 mm (H) x 0.197
mm (V) | same |
| 1.7 | Response time
(typical) | 28ms | 28ms | same |
| 1.8 | Brightness
(typical) | 1300cd/m² | 1300cd/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 | 10bit | 10bit | same |
| | 2.Video Signals | | | |
| 2.1 | Input video signals | DVI-D (dual link) x 1, DisplayPort x 2 | DVI-D (dual link) x 1, DisplayPort x 2 | same |
| 2.2 | Digital Scanning Frequency (H, V) | 1P DVI :
Horizontal: 63.3KHz
Vertical: 30.0Hz
1P DP
Horizontal: 128.3KHz
Vertical: 60Hz
2P DVI:
Horizontal: 128.3KHz
Vertical: 60.0Hz
2P DP
Horizontal: 128.3KHz
Vertical: 60.0Hz | 1P DVI :
Horizontal: 63.3KHz
Vertical: 30.0Hz
1P DP
Horizontal: 128.3KHz
Vertical: 60Hz
2P DVI:
Horizontal: 128.3KHz
Vertical: 60.0Hz
2P DP
Horizontal: 128.3KHz
Vertical: 60.0Hz | same |
| 2.3 | Video bandwidth | DVI: 217.75/ 441.5 231.00 MHz
DisplayPort: 441.5/ 231.00 MHz | DVI: 217.75/ 441.5 231.00 MHz
DisplayPort: 441.5/ 231.00 MHz | same |
| | 3.Power Related Specifications | | | |
| 3.1 | Power Requirements | 100-240VAC 50/60Hz | 100-240VAC 50/60Hz | same |
| 3.2 | Maximum power consumption | 160W | 160W | same |
| 3.3 | Power save mode | Less than 0.5 W | Less than 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 | Integrated front sensor
Ambient sensor
Presence sensor | Integrated front sensor
Ambient sensor
Presence sensor | same |
| 4.3 | USB Ports | 1 USB-1
2 USB Upstream Port
4 USB Downstream
Port/ Rev. 2.0 | 1 USB-1
2 USB Upstream Port
4 USB Downstream
Port/ Rev. 2.0 | same |
| 4.4 | Brightness
stabilization | Yes | Yes | same |
| 4.5 | Net weight | 18.7 kg | 18.7 kg | same |
| 4.6 | Dimensions w/o
stand (W x H x D) | With base: 687.14 x
531.11 ~ 631.11 x
264.00 mm | With base: 687.14 x
531.11 ~ 631.11 x
264.00 mm | 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 |
16
17
The technological characteristics differences discussed above do not affect the safety and the effectiveness of the C310S, G310S, C316S, C616W. The major changes include: 1) calibration tools, which have been validated according to IEC 62304, and 2) its module, which also has been verified and validated through physical laboratory testing conducted according to the FDA Guidance, "Display Devices for Diagnostic Radiology".
Based on the physical laboratory test results and software validation reports, all the differences between the proposed and predicate device do not raise any concerns regarding safety and effectiveness of the device.
Therefore, the proposed device is substantially equivalent to the predicate device in terms of its indications for use and technological characteristics.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The following data were provided in support of the substantial equivalence determination:
- Software Validation
The display embedded software contain software that belongs to Basic Documentation Level. The
18
software was designed and developed according to a software development process and was verified and validated.
Its calibration tools, DBI Calibration Feedback System(CFS), belong to Basic Documentation Level.
The software programs were verified and validated according to IEC 62304. Software information is provided in accordance with FDA quidance:
- The content of premarket submissions for Device Software Functions (June 14, 2023)
-
- Cybersecurity
Cybersecurity documents are provided in accordance with the below FDA guidance:
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ● Submissions (September 27, 2023)
- Postmarket Management of Cybersecurity in Medical Devices (December 28, 2016)
-
- Bench Test Performance Test
- Physical Laboratory Test items suggested in the FDA guidance "Display Devices for Diagnostic ● Radiology" were tested on the display embedded software using DBI Calibration Feedback System on C310S, G310S, C316S, G316S, C616W and the test result as follows:
| Measurements | Description | Test result |
|---|---|---|
| 1. Spatial resolution | Measurement of spatial resolution expressed as modulation transfer function (MTF) | PASS |
| 2. Pixel defects | The maximum number allowed for each type of pixel defects/faults | PASS |
| 3. Artifacts | Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline | PASS |
| 4. Temporal response | Measure the temporal response using the typical data provided by the panel manufacturer | PASS |
| 5. Luminance (maximum, minimum, achievable, and recommended) | Meausure the maximum, minimum, achievable, and recommended luminance | PASS |
| 6. Conformance to a grayscale-to luminance function | Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline) | PASS |
| 7. Color tracking (primary colors and color gamut) | Measurement of Color tracking (primary colors and color gamut) | PASS |
19
All display characteristics of the display embedded software have met the pre-determined criteria. Therefore, the test results showed that C310S, G310S, C316S, C616W are with display characteristics equivalent to those of the predicate devices.
No animal or clinical testing is needed for C310S, C316S, G316S, C616W.
8. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd. concludes that
- There are no significant differences between the proposed device and the predicate device that would negatively impact its use and safety.
- The proposed device has been proved to be as safe and effective as the predicate device, which was previously cleared in K240310.
- It shares the same indications for use and similar technological characteristics, with any differences supported by software validation reports and performance test results that demonstrate the proposed device's safety and effectiveness.
- The technological differences between the proposed device and its predicate device do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate device.