(57 days)
MS-S500, CL-S500
MS-S500, CL-S500
No
The device description and intended use focus on the technical specifications and performance of medical monitors for displaying images, with no mention of AI or ML capabilities for image analysis or processing.
No.
The device is a medical image display monitor used for viewing diagnostic images, not for providing therapy.
No
This device is a medical image display monitor used by medical practitioners for diagnosis, but it does not perform the diagnosis itself. It is a tool that facilitates diagnosis.
No
The device description explicitly states it is a 21.3-inch TFT LCD monitor, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The description clearly states that these are LCD monitors intended for displaying and viewing medical images. They are used in conjunction with imaging modalities like digital mammography and digital breast tomosynthesis.
- Lack of Specimen Analysis: The device does not interact with or analyze biological specimens. Its function is solely to present images generated by other medical devices.
Therefore, while these monitors are crucial for medical diagnosis, they fall under the category of medical imaging display devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Product codes
PGY
Device Description
5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S 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 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, 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.
C510S, CB5MP, C516S have the same color LCD panel and similar functionality. The difference between C510S and CB5MP is only different customers which results in the two models. For C510S, CB5MP, C516S, the difference is the main board and design principle.
G510S, MB5MP, G516S have the same monochrome LCD panel and similar functionality. The difference between G510S and MB5MP is only different customers which results in the two models. For G510S, MB5MP, G516S, the difference is the main board and design principle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners or certified personnel.
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)
According to the instructions in" Guidance for Industry and Food and Drug Administration Staff Display Devices for Diagnostic Radiology", the bench tests were performed on C510S, G510S, CB5MP, MB5MP, C516S, G516S as below.
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 quideline).
- Measure the calibrated luminance according to the requirements of the "Luminance Response" test in TG18 guideline.
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the luminance stability and chromaticity response with the temperature 0 degree Celsius, 25 degree Celsius and 40 degree Celsius on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- Measure the luminance at the angles of 30% and 45 degree in diagonal, horizontal and vertical directions at center and four corners by AAPM-TG18.
- Measure the temporal response using the typical data provided by the panel manufacturer.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial noise by noise power spectrum.
- Measure the reflection coefficient with specular reflection and diffuse reflection by TG18.
- Measure the veiling glare of small-spot contrast performing veiling glare test by TG-18.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
- Measurement of Color tracking and Gray tracking
- Measure pixel fill factor like pixel structure and aperture ratio etc.
The test results showed that C510S, G510S, CB5MP, MB5MP, C516S, G516S are with display characteristics equivalent to those of the predicate devices, MS-S500, CL-S500 except some items, each of which was determined that it would not affect observer's performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Beacon Display Technology Co., Ltd. Li Yafei Official Correspodent 15F, Building 6, Hengda Shishang Huigu (East) Fulong Road, Dalang Subdistrict, Longhua Shenzhen, Guangdong 518109, China
February 6, 2024
Re: K233897
Trade/Device Name: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S. CB5MP, MB5MP, C516S, G516S) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PGY Dated: December 11, 2023 Received: December 11, 2023
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/cdrh/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.
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).
1
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 QS 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.
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 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
2
Indications for Use
510(k) Number (if known) K233897
Device Name
5MP Color LCD Monitors C510S, CB5MP, C516S. 5MP Monochrome LCD Monitors G510S, MB5MP, G516S.
Indications for Use (Describe)
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
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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3
510 (k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Feb 04, 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: | liyf@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| ● Trade Name/Model: | 5MP Color LCD Monitors C510S, CB5MP, C516S.
5MP Monochrome LCD Monitors G510S, MB5MP, G516S. |
|-------------------------|-------------------------------------------------------------------------------------------------|
| ● Common Name: | 5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S,
G516S |
| ● 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)]
5
The identified predicate within this submission is as follows:
JVC Kenwood Corporation, 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 has been cleared by FDA through 510(k) No. K191137 (Decision Date -July 2, 2019).
5. Description of the Device [21 CFR 807.92(a) (4)]
5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S 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 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, 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.
C510S, CB5MP, C516S have the same color LCD panel and similar functionality. The difference between C510S and CB5MP is only different customers which results in the two models. For C510S, CB5MP, C516S, the difference is the main board and design principle.
G510S, MB5MP, G516S have the same monochrome LCD panel and similar functionality. The difference between G510S and MB5MP is only different customers which results in the two models. For G510S, MB5MP, G516S, the difference is the main board and design principle.
6. Indications for use
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
6
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel characteristics: | |
|---|---|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
| Active area (H x V) | 422.4 x 337.92 mm |
| Pixel pitch | 0.165 mm (H) x 0.165 mm (V) |
| Resolution | 2560 x 2048 |
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical) |
| Vertical: 178° (Typical) | |
| Screen brightness | 1150 cd/m² (typical) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| Power supply: | |
| Line voltage | DC 24 V |
| Current consumption | 5.0 A |
| Power consumption | 10) |
| Vertical: 178° (Typical) | |
| Screen brightness | 3000 cd/m² (typical) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Power supply: | |
| Line voltage | DC 24 V |
| Current consumption | 5.0 A |
| Power consumption | 10) |
| Vertical: 178° (Typical) | |
| Screen brightness | 1150 cd/m² (typical) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| Power supply: | |
| Power connection | Adapter |
| Output | +24VDC, 5.0A |
| Power consumption: | |
| Normal Mode | 100W (Maximum) |
| Standby Mode | 0.5 W (Maximum) |
| Control and connection : | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch1 DC Input1 DVI-D1 DP2 DP-OUT1 USB-A1 USB Upstream Port2 USB Downstream Port4 |
| Mechanical characteristics : | |
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| Climatic conditions : | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| Safety regulations : | |
| Safety standards | IEC 60601-1, IEC 60601-1-2 |
| EN 60601-1, EN 60601-1-2 | |
| ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1 | |
| CAN/CSA-C22.2 NO. 60601-1:14 | |
| Conformity | CCC, CE, FCC, cTUVus, Energy Conservation |
| Certification | |
| Dimension: | |
| With packing(W x H x D) | 483 x 321 x 627 mm |
| Weight: | |
| Gross weight | Approximate $13.3 \pm 0.5$ kg |
| Net weight | Approximate $9.3 \pm 0.5$ kg |
10
510(k) Summary
11
G516S Monochrome LCD Monitor
| Panel characteristics: | ||
|---|---|---|
| Screen technology | 21.3", TFT, grayscale, LCD screen, anti-glare, hard coating | |
| Active area(H x V) | 422.4 x 337.92 mm | |
| Pixel pitch | 0.165 mm(H) x 0.165 mm(V) | |
| Resolution | 2560 x 2048 | |
| Contrast ratio | 2000:1 (typical), 1600:1 (minimal) | |
| Viewing angle(CR > 10) | Horizontal: 178°(Typical) | |
| Vertical: 178°(Typical) | ||
| Screen brightness | 3000 cd/m²(typical) | |
| Refresh rate | 50 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50,000 hours | |
| Response time(TR+TF) | 11 + 14 ms(typical) | |
| Power supply: | ||
| Power connection | Adapter | |
| Output | +24VDC, 5.0A | |
| Power consumption: | ||
| Normal Mode | 100W (Maximum) | |
| Standby Mode | 0.5 W (Maximum) | |
| Control and connection : | ||
| Front | 1 operation LED, 6 functional keys | |
| Back | Power switch1 DC Input1 DVI-D1 DP2 DP-OUT1 USB-A1 USB Upstream Port2 USB Downstream Port4 | |
| Mechanical characteristics : | ||
| Housing components | Plastic | |
| Ventilation openings | Natural heat radiation | |
| Degree of protection | IP20 | |
| Climatic conditions : | ||
| Working temperature | 0°C - 40°C | |
| Working humidity | 15% - 85% Relative humidity, no condensation | |
| Transport and storage temperature | -20°C - 60°C | |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation | |
| Air pressure | 700hPa - 1060hPa | |
| Safety regulations : | ||
| Safety standards | IEC 60601-1, IEC 60601-1-2 | |
| EN 60601-1, EN 60601-1-2 | ||
| ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1 | ||
| CAN/CSA-C22.2 NO. 60601-1:14 | ||
| Conformity | CCC, CE, FCC, cTUVus, Energy Conservation | |
| Certification | ||
| Dimension: | ||
| With packing(W x H x D) | 483 x 321 x 627 mm | |
| Weight: | ||
| Gross weight | Approximate 13.3 ± 0.5 kg | |
| Net weight | Approximate 9.3 ± 0.5 kg |
12
510(k) Summary
13
14
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Indication for use:
| ID | Comparison Item | Proposed Device
5MP Color LCD Monitors C510S, CB5MP,
C516S.
5MP Monochrome LCD Monitors G510S,
MB5MP, G516S. | Predicate Device
5MP Color LCD Monitor CL-S500,
5MP Monochrome LCD Monitor MS-S500 | | |
|------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1 | Indication for use | C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM. | CL-S500 and MS-S500 are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM. | | |
| ID | Comparison
Item | Proposed Device
5MP Color LCD Monitors
C510S, CB5MP | Predicate Device
5MP Color LCD Monitor
CL-S500 | Explanation of Differences | |
| 2 | Display Performance/Specifications | | | | |
| 2.1 | Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - | |
| 2.2 | Viewing angle (H, V) | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | CR>50
Horizontal: Typ.178
Vertical: Typ.178 | Different screen provided by the
different manufacturer | |
| 2.3 | Resolution or
matrix size | 5MP(2560 x 2048) | 5MP(2048 X 2560) | - | |
| 2.4 | Aspect ratio | 5:4 | 4:5 | - | |
| 2.5 | Display area | Horizontal: 422.4mm
Vertical: 337.92mm | Horizontal: 337.92mm
Vertical: 422.4mm | - | |
| 2.6 | Pixel pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - | |
| 2.7 | Response time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - | |
| 2.8 | Maximum luminance | Min. 920cd/m²
Typ. 1,150cd/m² | Min. 920cd/m²
Typ. 1,150cd/m² | - | |
| 2.9 | DICOM calibrated
luminance | 450cd/m² | 500cd/m² | Difference complies the DICOM
3.14. | |
| 2.10 | Contrast ratio | Min. 1600:1
Typ. 2000:1 | Min. 1600:1
Typ. 2000:1 | - | |
| 2.11 | Backlighting | LED | LED | - | |
| 2.12 | Grayscale 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 | 10-bit (DisplayPort): 1.073
billion
1024 from a palette of 16,369
tones
8-bit(DVI): 16.77 million 256
from a palette of 16,369 tones | Tone between the predicate
device and our proposed
devices are different. But they
pass the exams in AAPM-TG18
4.3 "Luminance Response".
Therefore, they are equivalent
to the predicate device. | |
| 2.13 | Luminance
non-uniformity
compensation | - | Digital Uniformity Correction
System | Different design scheme | |
| 3 | Video Signals | | | | |
| 3.1 | Input video signals | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | - | |
| 3.2 | Scanning Frequency
(H, V) | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | Different design scheme | |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - | |
| 4 | Power Related Specifications | | | | |
| 4.1 | Power Requirements | DC 24V, 5A | AC 100-240V, 50/60Hz | Difference between built-in
power supply and built-out
power supply | |
| 4.2 | Power Consumption /
Save Mode | 100W
Less than 0.5W | 95W
Less than 1W | Compared with the predicate
device, the proposed device
consumes more power in the
operating mode and less power
in the power saving mode. | |
| 4.3 | Power Management | VESA DPMS and EPA power
saving,
DisplayPort 1.2 | DVI DMPM,
DisplayPort 1.2a | Different design scheme | |
| 5 | Miscellaneous Features/Specifications | | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/
Calibration Feedback System | QA Medivisor/ Medivisor
NXF-CAL | Different design scheme | |
| 5.2 | Sensors | Built-in Front Sensor
Built-in Ambient Light Sensor
Built-in Backlight Sensor | Built-in Front Sensor
Built-in Ambient Light Sensor | Different design scheme | |
| 5.3 | USB Ports/Standard | 2 upstream,
4 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | | |
| 5.4 | Dimensions with
stand (W x H x D) | 360.5 x 513.49/613.49 x 224
mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to
the different panel size | |
8.2 Comparison table
15
Table 2 General Comparison of C510S, CB5MP
16
17
18
| ID | Comparison
Item | Proposed Device
5MP Monochrome LCD
Monitors G510S, MB5MP | Predicate Device
5MP Monochrome LCD
Monitor MS-S500 | Explanation of Differences |
|------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen Technology | TFT Monochrome LCD Panel
(IPS) | TFT Monochrome LCD Panel
(IPS) | - |
| 2.2 | Viewing angle (H, V) | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | CR>50
Horizontal: Typ.178
Vertical: Typ.178 | Different screen provided by the
different manufacturer |
| 2.3 | Resolution or
matrix size | 5MP (2560 X 2048) | 5MP (2048 X 2560) | - |
| 2.4 | Aspect ratio | 5: 4 | 4:5 | - |
| 2.5 | Display Area | Horizontal: 422.4mm
Vertical: 337.92mm | Horizontal: 337.92mm
Vertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - |
| 2.7 | Response Time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 2,400cd/m²
Typ. 3,000cd/m² | Min. 2,400cd/m²
Typ. 3,000cd/m² | - |
| 2.9 | DICOM calibrated
luminance | 450cd/m² | 1,000cd/m² | Difference complies the DICOM
3.14. |
| 2.10 | Contrast ratio | Min. 1600:1
Typ. 2000:1 | Min. 1600:1
Typ. 2000:1 | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | 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 16,369 tones
8-bit (DVI): 256 from a palette
of 16,369 tones | Tone between the predicate
device and our proposed
devices are different. But they
pass the exams in AAPM-TG18
4.3 "Luminance Response".
Therefore, they are equivalent
to the predicate device. |
| 2.13 | Luminance
non-uniformity
compensation | - | Digital Uniformity Correction
System | Different design scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video signals | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | - |
| 3.2 | Scanning Frequency
(H, V) | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | Different design scheme |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 24V, 5.0A | AC 100-240V, 50/60Hz | Difference between built-in
power supply and built-out
power supply |
| 4.2 | Power Consumption /
Save Mode | 100W
Less than 0.5W | 80W
Less than 1W | Compared with the predicate
device, the proposed device
consumes more power in the
operating mode and less power
in the power saving mode. |
| 4.3 | Power Management | VESA DPMS and EPA power
saving,
DisplayPort 1.2 | DVI DMPM,
DisplayPort 1.2a | Different design scheme |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/
Calibration Feedback System | QA Medivisor/ Medivisor
NXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor
Built-in Ambient Light Sensor
Built-in backlight sensor | Built-in Front Sensor
Built-in Ambient Light Sensor | Different design scheme |
| 5.3 | USB Ports/Standard | 2 upstream,
4 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | - |
| 5.4 | Dimensions with
stand (W x H x D) | 360.5 x 513.49/613.49 x 224
mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to
the different panel size |
Table 3 General Comparison of G510S, MB5MP
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20
Table 4 General Comparison of C516S
| ID | Comparison
Item | Proposed Device
5MP Color LCD Monitors
C516S | Predicate Device
5MP Color LCD Monitor
CL-S500 | Explanation of Differences |
|------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| 2.2 | Viewing angle (H, V) | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | CR>50
Horizontal: Typ.178
Vertical: Typ.178 | Different screen provided by the
different manufacturer |
| 2.3 | Resolution or
matrix size | 5MP(2560 x 2048) | 5MP(2048 X 2560) | - |
| 2.4 | Aspect ratio | 5:4 | 4:5 | - |
| 2.5 | Display area | Horizontal: 422.4mm
Vertical: 337.92mm | Horizontal: 337.92mm
Vertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - |
| 2.7 | Response time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 920cd/m²
Typ. 1,150cd/m² | Min. 920cd/m²
Typ. 1,150cd/m² | - |
| 2.9 | DICOM calibrated
luminance | 450cd/m² | 500cd/m² | Difference complies the DICOM
3.14. |
| 2.10 | Contrast ratio | Min. 1600:1
Typ. 2000:1 | Min. 1600:1
Typ. 2000:1 | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | Grayscale 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 | 10-bit (DisplayPort): 1.073 billion
1024 from a palette of 16,369 tones
8-bit(DVI): 16.77 million 256 from a palette of 16,369 tones | Tone between the predicate device and our proposed devices are different. But they pass the exams in AAPM-TG18 4.3 "Luminance Response" . Therefore, they are equivalent to the predicate device. |
| 2.13 | Luminance non-uniformity compensation | - | Digital Uniformity Correction System | Different design scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video signals | DVI-D x1
DisplayPort x2 | DVI-D x1
DisplayPort x1 | Different design scheme |
| 3.2 | Scanning Frequency (H, V) | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | Different design scheme |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 24V, 5A | AC 100-240V, 50/60Hz | Difference between built-in power supply and built-out power supply |
| 4.2 | Power Consumption /
Save Mode | 100W
Less than 0.5W | 95W
Less than 1W | Compared with the predicate
device, the proposed device
consumes more power in the
operating mode and less power
in the power saving mode. |
| 4.3 | Power Management | VESA DPMS and EPA power
saving,
DisplayPort 1.2 | DVI DMPM,
DisplayPort 1.2a | Different design scheme |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/
Calibration Feedback System | QA Medivisor/ Medivisor
NXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor
Built-in Ambient Light Sensor
Built-in Backlight Sensor
Built-in Presence Sensor
Gravity Sensor | Built-in Front Sensor
Built-in Ambient Light Sensor | Different design scheme |
| 5.3 | USB Ports/Standard | 2 upstream,
4 downstream / Rev. 2.0
1 USB-A/ Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | |
| 5.4 | Dimensions with
stand (W x H x D) | 360.5 x 513.49/613.49 x 224
mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to
the different panel size |
21
22
23
24
| ID | Comparison
Item | Proposed Device
5MP Monochrome LCD
Monitors G516S | Predicate Device
5MP Monochrome LCD
Monitor MS-S500 | Explanation of Differences |
|------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen Technology | TFT Monochrome LCD Panel
(IPS) | TFT Monochrome LCD Panel
(IPS) | - |
| 2.2 | Viewing angle (H, V) | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | CR>50
Horizontal: Typ.178
Vertical: Typ.178 | Different screen provided by the
different manufacturer |
| 2.3 | Resolution or
matrix size | 5MP (2560 X 2048) | 5MP (2048 X 2560) | - |
| 2.4 | Aspect ratio | 5: 4 | 4:5 | - |
| 2.5 | Display Area | Horizontal: 422.4mm
Vertical: 337.92mm | Horizontal: 337.92mm
Vertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - |
| 2.7 | Response Time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 2,400cd/m²
Typ. 3,000cd/m² | Min. 2,400cd/m²
Typ. 3,000cd/m² | - |
| 2.9 | DICOM calibrated
luminance | 450cd/m² | 1,000cd/m² | Difference complies the DICOM
3.14. |
| 2.10 | Contrast ratio | Min. 1600:1
Typ. 2000:1 | Min. 1600:1
Typ. 2000:1 | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | 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 16,369 tones
8-bit (DVI): 256 from a palette
of 16,369 tones | Tone between the predicate
device and our proposed
devices are different. But they
pass the exams in AAPM-TG18
4.3 "Luminance Response"
Therefore, they are equivalent
to the predicate device. |
| 2.13 | Luminance
non-uniformity
compensation | - | Digital Uniformity Correction
System | Different design scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video signals | DVI-D x1
DisplayPort x2 | DVI-D x1
DisplayPort x1 | - |
| 3.2 | Scanning Frequency
(H, V) | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | Different design scheme |
| 3.3 | Dot Clock | 285.2 MHz | 285 MHz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 24V, 5.0A | AC 100-240V, 50/60Hz | Difference between built-in
power supply and built-out
power supply |
| 4.2 | Power Consumption /
Save Mode | 100W
Less than 0.5W | 80W
Less than 1W | Compared with the predicate
device, the proposed device
consumes more power in the
operating mode and less power
in the power saving mode. |
| 4.3 | Power Management | VESA DPMS and EPA power
saving,
DisplayPort 1.2 | DVI DMPM,
DisplayPort 1.2a | Different design scheme |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | Calibration tools | Beacon Monitor Manage/
Calibration Feedback System | QA Medivisor/ Medivisor
NXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor
Built-in Ambient Light Sensor
Built-in Backlight Sensor
Built-in Presence Sensor
Gravity Sensor | Built-in Front Sensor
Built-in Ambient Light Sensor | Different design scheme |
| 5.3 | USB Ports/Standard | 2 upstream,
4 downstream / Rev. 2.0
1 USB-A/ Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | |
| 5.4 | Dimensions with
stand (W x H x D) | 360.5 x 513.49/613.49 x 224
mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to
the different panel size |
Table 5 General Comparison of G516S
25
26
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The technological characteristics differences discussed above do not affect the safety and the effectiveness of the C510S, G510S, CB5MP, MB5MP, C516S, G516S.
8.3 Performance Testing
According to the instructions in" Guidance for Industry and Food and Drug Administration Staff Display Devices for Diagnostic Radiology", the bench tests were performed on C510S, G510S, CB5MP, MB5MP, C516S, G516S as below.
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 quideline).
- Measure the calibrated luminance according to the requirements of the "Luminance Response" test in TG18 guideline.
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the luminance stability and chromaticity response with the temperature 0 ℃, 25°C and 40°C on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- Measure the luminance at the angles of 30% and 45º in diagonal, horizontal and vertical directions at center and four corners by AAPM-TG18.
- Measure the temporal response using the typical data provided by the panel manufacturer.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial noise by noise power spectrum.
- Measure the reflection coefficient with specular reflection and diffuse reflection by TG18.
- Measure the veiling glare of small-spot contrast performing veiling glare test by TG-18.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
- Measurement of Color tracking and Gray tracking
28
- Measure pixel fill factor like pixel structure and aperture ratio etc.
The test results showed that C510S, G510S, CB5MP, MB5MP, C516S, G516S are with display characteristics equivalent to those of the predicate devices, MS-S500, CL-S500 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C510S, CB5MP, MB5MP, C516S, G516S.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug 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:
- The intended use of C510S, G510S, CB5MP, MB5MP, C516S, G516S is totally same as that of the predicate devices.
- The technological characteristics differences between C510S, G510S, CB5MP, MB5MP, C516S, G516S and the predicate devices do not affect the safety and effectiveness, so no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C510S, G510S, CB5MP, MB5MP, C516S, G516S are equivalent to those of the predicate devices.