(28 days)
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.
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.
The provided text describes a 510(k) summary for several LCD medical displays (C310S, G310S, C316S, G316S, C616W) which are claimed to be substantially equivalent to a previously cleared device (K240310). The information does not detail an AI-powered device or a study involving human readers or comparative effectiveness for AI assistance. Instead, it focuses on the technical specifications and performance of the LCD monitors.
Therefore, the following information is extracted and parts that are not relevant to an AI/ML powered device or are not provided in the text are explicitly stated as such.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the "Description" column, indicating what was measured, and the "Test result" column, which uniformly states "PASS". This suggests that the measured performance met the predetermined criteria for each test.
| Measurements | Description | Test result | Acceptance Criteria (Implied) |
|---|---|---|---|
| 1. Spatial resolution | Measurement of spatial resolution expressed as modulation transfer function (MTF) | PASS | Meet predefined MTF standards |
| 2. Pixel defects | The maximum number allowed for each type of pixel defects/faults | PASS | Not exceed maximum allowed pixel defects/faults |
| 3. Artifacts | Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline | PASS | Absence of miscellaneous artifacts as per TG18 |
| 4. Temporal response | Measure the temporal response using the typical data provided by the panel manufacturer | PASS | Meet manufacturer's typical temporal response data |
| 5. Luminance (maximum, minimum, achievable, and recommended) | Meausure the maximum, minimum, achievable, and recommended luminance | PASS | Meet specified luminance ranges |
| 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 | Conformance to DICOM GSDF as per TG18 |
| 7. Color tracking (primary colors and color gamut) | Measurement of Color tracking (primary colors and color gamut) | PASS | Meet specified color tracking and gamut standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are physical laboratory tests on the display embedded software using DBI Calibration Feedback System on the monitors, not a test on a test set of medical cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the device is an LCD monitor, not an AI / image analysis software requiring expert annotation for ground truth. The tests are technical performance evaluations of the display.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's not relevant for the type of device being described (an LCD monitor).
5. 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an LCD monitor, not an AI or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study was not done as this device is an LCD monitor, which is a display hardware, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the performance tests of the LCD monitors is based on pre-determined technical criteria and industry standards (e.g., DICOM Part 3.14, AAPM Task Group 18 guideline, manufacturer's typical data). This is not a "ground truth" derived from medical diagnosis but from established engineering and display performance metrics.
8. The sample size for the training set
This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is an LCD monitor and does not involve AI/ML models that require a training set and ground truth generation.
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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.
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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
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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)
< Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
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, DalangSubdistrict, 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)]
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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 | ComparisonItem | Proposed Device | Predicate DeviceK240310 | Explanation ofDifferences |
|---|---|---|---|---|
| C310S | C310S | |||
| 1.Display Performance/Specifications | ||||
| 1.1 | Displaytechnology | 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 | Nativeresolution | 1536 x 2048 | 1536 x 2048 | same |
| 1.5 | Viewable imagesize (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 | Recommendedbrightness | 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 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones | 10-bit (DisplayPort):1.073 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones | same |
| 2.Video Signals | ||||
| 2.1 | Input videosignals | DVI-D (dual link) x 1,DisplayPort x 1 | DVI-D (dual link) x 1,DisplayPort x 1 | same |
| 2.2 | Digital ScanningFrequency (H, V) | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | same |
| 2.3 | Videobandwidth | DVI: 214.25 MHzDisplayPort: 214.25 MHz | DVI: 214.25 MHzDisplayPort: 214.25 MHz | same |
| 3.Power Related Specifications | ||||
| 3.1 | PowerRequirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same |
| 3.2 | Maximum powerconsumption | 100 W | 100 W | same |
| 3.3 | Power savemode | Less than or equal to0.5 W | Less than or equal to0.5 W | same |
| 3.4 | PowerManagement | VESA DPMS andEPA power savingmanagement,DisplayPort 1.2 | VESA DPMS andEPA power savingmanagement,DisplayPort 1.2 | same |
| 4.Miscellaneous Features/Specifications | ||||
| 4.1 | Calibration Tool | Beacon MonitorManage/ CalibrationFeedback System | Beacon MonitorManage | Different |
| 4.2 | Sensors | Backlight sensorIntegrated front sensorAmbient sensor | Backlight sensorIntegrated front sensorAmbient sensor | same |
| 4.3 | USB Ports | 2 USB Upstream Port4 USB DownstreamPort | 2 USB Upstream Port4 USB DownstreamPort | same |
| 4.4 | Brightnessstabilization | Yes | Yes | same |
| 4.5 | Net weight | $8.2 \pm 0.5$ kg | $8.2 \pm 0.5$ kg | same |
| 4.6 | Dimensions w/ostand (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 forUse | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | same |
Table 1 General Comparison of C310S
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Table 2 General Comparison of C316S
| ID | ComparisonItem | Proposed Device | Predicate DeviceK240310 | Explanation ofDifferences |
|---|---|---|---|---|
| C316S | C316S | |||
| 1.Display Performance/Specifications | ||||
| 1.1 | Displaytechnology | 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 | Nativeresolution | 1536 x 2048 | 1536 x 2048 | same |
| 1.5 | Viewable imagesize (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 | Recommendedbrightness | 450 cd/m² | 450 cd/m² | same |
| 1.10 | Contrast ratio(typical) | 2000:1 | 2000:1 | same |
| 1.11 | Backlight type | LED | LED | same |
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| 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 | |||
| consumptionPower 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 MonitorManage/ 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 | Brightnessstabilization | Yes | Yes | same |
|---|---|---|---|---|
| 4.5 | Net weight | $8.6 \pm 0.5$ kg | $8.6 \pm 0.5$ kg | same |
| 4.6 | Dimensions w/ostand (W x H xD) | 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 forUse | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | same |
Table 3 General Comparison of G310S
| ID | ComparisonItem | Proposed Device | Predicate DeviceK240310 | Explanation ofDifferences |
|---|---|---|---|---|
| G310S | G310S | |||
| 1.Display Performance/Specifications | ||||
| 1.1 | Displaytechnology | TFT MonochromeLCD Panel (IPS) | TFT MonochromeLCD Panel (IPS) | same |
| 1.2 | Screen size | 54.1 cm / 21.3" (541mm diagonal) | 54.1 cm / 21.3" (541mm diagonal) | same |
| 1.3 | Viewing angle(H/V) | 178°/178° | 178°/178° | same |
| 1.4 | Nativeresolution | 1536 x 2048 (3:4aspect ratio) | 1536 x 2048 (3:4aspect ratio) | same |
| 1.5 | Viewable imagesize (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same |
| 1.6 | Pixel pitch | 0.2115 mm (H) x0.2115 mm (V) | 0.2115 mm (H) x0.2115 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 | Recommendedbrightness | 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 | GrayscaleTones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones8-bit (DVI): 256 from apalette of 16,384tones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones8-bit (DVI): 256 from apalette of 16,384tones | same |
| 2.Video Signals | ||||
| 2.1 | Input videosignals | DVI-D (dual link) x 1DisplayPort x 1 | DVI-D (dual link) x 1DisplayPort x 1 | same |
| 2.2 | Digital ScanningFrequency (H, V) | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | same |
| 2.3 | Dot Clock | DVI: 214.25 MHzDisplayPort: 214.25MHz | DVI: 214.25 MHzDisplayPort: 214.25MHz | same |
| 3.Power Related Specifications | ||||
| 3.1 | PowerRequirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same |
| 3.2 | Maximum powerconsumption | 60 W | 60 W | same |
| 3.3 | Power savemode | Less than or equal to0.5 W | Less than or equal to0.5 W | same |
| 3.4 | PowerManagement | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | same |
| 4.Miscellaneous Features/Specifications | ||||
| 4.1 | Calibration Tool | Beacon MonitorManage/ CalibrationFeedback System | Beacon MonitorManage | Different |
| 4.2 | Sensors | Backlight sensorIntegrated front sensorAmbient sensor | Backlight sensorIntegrated front sensorAmbient sensor | same |
| 4.3 | USB Ports | 2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | 2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | same |
| 4.4 | Brightnessstabilization | Yes | Yes | same |
| 4.5 | Net weight | 8.2 ± 0.5 | 8.2 ± 0.5 | same |
| 4.6 | Dimensions w/ostand (W x H xD) | 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 isintended to be used indisplaying and viewingdigital images fordiagnosis of X-ray orMRI, etc. by trainedmedical practitioners.This product is notspecified for digitalmammographysystems. | This product isintended to be used indisplaying and viewingdigital images fordiagnosis of X-ray orMRI, etc. by trainedmedical practitioners.This product is notspecified for digitalmammographysystems. | same |
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510(k) Submission
Table 4 General Comparison of G316S
| ID | ComparisonItem | Proposed DeviceG316S | Predicate DeviceK240310G316S | Explanation ofDifferences |
|---|---|---|---|---|
| 1.Display Performance/Specifications | ||||
| 1.1 | Displaytechnology | TFT MonochromeLCD Panel (IPS) | TFT MonochromeLCD 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 | Nativeresolution | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | same |
| 1.5 | Viewable imagesize (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | same |
| 1.6 | Pixel pitch | 0.2115 mm (H) x0.2115 mm (V) | 0.2115 mm (H) x0.2115 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 | Recommendedbrightness | 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 | GrayscaleTones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones | same |
| 8-bit (DVI): 256 from apalette of 16,384tones | 8-bit (DVI): 256 from apalette of 16,384tones | |||
| 2.Video Signals | ||||
| 2.1 | Input videosignals | DVI-D (dual link) x 1DisplayPort x 1 | DVI-D (dual link) x 1DisplayPort x 1 | same |
| 2.2 | Digital ScanningFrequency (H, V) | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | same |
| 2.3 | Dot Clock | DVI: 216 MHzDisplayPort: 216 MHz | DVI: 216 MHzDisplayPort: 216 MHz | same |
| 3.Power Related Specifications | ||||
| 3.1 | PowerRequirements | DC 24V/ 5.0A | DC 24V/ 5.0A | same |
| 3.2 | Maximum powerconsumption | 60 W | 60 W | same |
| 3.3 | Power savemode | Less than or equal to0.5 W | Less than or equal to0.5 W | same |
| 3.4 | PowerManagement | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | same |
| 4.Miscellaneous Features/Specifications | ||||
| 4.1 | Calibration Tool | Beacon MonitorManage/ CalibrationFeedback System | Beacon MonitorManage | Different |
| 4.2 | Sensors | Backlight sensorIntegrated front sensorAmbient sensorPresence sensorGravity sensor | Backlight sensorIntegrated front sensorAmbient sensorPresence sensorGravity sensor | same |
| 4.3 | USB Ports | 1 USB-A2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | 1 USB-A2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | same |
| 4.4 | Brightnessstabilization | 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 |
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Table 5 General Comparison of C616W
| ID | ComparisonItem | Proposed Device | Predicate DeviceK240310 | Explanation ofDifferences |
|---|---|---|---|---|
| C616W | C616W | |||
| 1.Display Performance/Specifications | ||||
| 1.1 | Displaytechnology | TFT Color LCD Panel(IPS) | TFT Color LCD Panel(IPS) | same |
| 1.2 | Screen size | 30" (Aspect Ratio16:10) | 30" (Aspect Ratio16:10) | same |
| 1.3 | Viewing angle(H/V) | H: 178°; V: 178° | H: 178°; V: 178° | same |
| 1.4 | Nativeresolution | 3280 x 2080 | 3280 x 2080 | same |
| 1.5 | Viewable imagesize (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 0.197mm (V) | 0.197 mm (H) x 0.197mm (V) | same |
| 1.7 | Response time(typical) | 28ms | 28ms | same |
| 1.8 | Brightness(typical) | 1300cd/m² | 1300cd/m² | same |
| 1.9 | Recommendedbrightness | 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: 63.3KHzVertical: 30.0Hz1P DPHorizontal: 128.3KHzVertical: 60Hz2P DVI:Horizontal: 128.3KHzVertical: 60.0Hz2P DPHorizontal: 128.3KHzVertical: 60.0Hz | 1P DVI :Horizontal: 63.3KHzVertical: 30.0Hz1P DPHorizontal: 128.3KHzVertical: 60Hz2P DVI:Horizontal: 128.3KHzVertical: 60.0Hz2P DPHorizontal: 128.3KHzVertical: 60.0Hz | same |
| 2.3 | Video bandwidth | DVI: 217.75/ 441.5 231.00 MHzDisplayPort: 441.5/ 231.00 MHz | DVI: 217.75/ 441.5 231.00 MHzDisplayPort: 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 sensorAmbient sensorPresence sensor | Integrated front sensorAmbient sensorPresence sensor | same |
| 4.3 | USB Ports | 1 USB-12 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | 1 USB-12 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | same |
| 4.4 | Brightnessstabilization | Yes | Yes | same |
| 4.5 | Net weight | 18.7 kg | 18.7 kg | same |
| 4.6 | Dimensions w/ostand (W x H x D) | With base: 687.14 x531.11 ~ 631.11 x264.00 mm | With base: 687.14 x531.11 ~ 631.11 x264.00 mm | same |
| 5. Indications for Use | ||||
| 5.1 | Indications for Use | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | same |
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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
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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 |
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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.
§ 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).