(48 days)
Not Found
No
The device description and performance studies focus on the display characteristics and calibration of the monitors, with no mention of AI or ML for image analysis or processing.
No.
The device is a medical image display monitor intended for diagnosis, not for treating a disease or condition.
No
Explanation: The device is described as a monitor intended for displaying and viewing medical images for diagnosis. It does not perform the diagnosis itself, but rather presents data for a human to interpret.
No
The device description explicitly details hardware components (21.3-inch TFT LCD monitors, LED backlight panel, built-in brightness stabilization control circuit, surface protection panels) and the performance studies focus on hardware characteristics (luminance, uniformity, stability, spatial resolution, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- 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.
- Intended Use: The intended use is for diagnosis by trained medical practitioners or certified personnel based on the visual interpretation of medical images. This is distinct from performing a diagnostic test on a biological sample.
The device is a medical image display device, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ 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 C53S+, C53SP+, G53S+, G53SP+ 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 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital mammography, digital breast tomosynthesis, FFDM
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)
The bench tests were performed on C53S+, C53SP+, G53S+, G53SP+ 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℃ and 40℃ on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the luminance at the angles of 300 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
- Measure pixel fill factor like pixel structure and aperture ratio etc.
The test results showed that C53S+, C53SP+, G53S+, G53SP+ 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 C53S+, C53SP+, G53S+, G53SP+.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Beacon Display Technology Co., Ltd. % Miss Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA
Re: K200864
Trade/Device Name: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: March 10, 2020 Received: April 1, 2020
May 19, 2020
Dear Miss Ailing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
March 10, 2020
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|---|---|
| Address: | 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road, Nanshan |
| District, Shenzhen, 518055 China | |
| Contact Name: | Fu Ailing |
| Telephone No.: | +86-0755-36868363-5150 |
| Fax No.: | +86-0755-26995755 |
| Email Address: | fuailing@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: 5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+ Common Name: 5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ Classification Name: Picture archiving and communications 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)]
The identified predicate within this submission is as follows:
3
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)1
5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ 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 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.
6. Intended Use [21 CFR 807.92(a)(5)]
The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
4
| Monitor characteristics : | |
|---|---|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
| Active area(H x V) | 337.92 x 422.4 mm |
| Pixel pitch | 0.165 mm (H) x 0.165 mm (V) |
| Resolution | 2048 x 2560 |
| Contrast ratio | 2000:1 (typical), 1600:1 (min.) |
| Viewing angle (CR > 10) | Horizontal: 178° (typ.) |
| Vertical: 178° (typ.) | |
| Screen brightness | 1150 cd/m² (typ.) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50000 hours |
| Response time (Ton + Toff) | 25 ms (typ.) |
| Power supply : | |
| Line voltage | 12 V |
| Current consumption | 6.67 A |
| Power consumption | 80 W (max.) |
| Standby | 10 ) |
| Vertical: 178° (typ.) | |
| Screen brightness | 3000 cd/m² (typ.) |
| Refresh rate | 50 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50000 hours |
| Response time ( Ton + Toff ) | 25 ms (typ.) |
| Power supply : | |
| Line voltage | 12 V |
| Current consumption | 6.67 A |
| Power consumption | 80 W (max.) |
| Standby | 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(2048 X 2560) |
| 2.4 | Aspect ratio |
| 2.5 | Display area |
| Vertical: 422.4mm | Horizontal: 337.92mm |
| Vertical: 422.4mm | - |
| 2.6 | Pixel pitch |
| Vertical: 0.165mm | Horizontal: 0.165mm |
| Vertical: 0.165mm | - |
| 2.7 | Response time (Typ.) |
| 2.8 | Maximum luminance |
| Typ. 1,150cd/m² | Min. 920cd/m² |
| Typ. 1,150cd/m² | - |
| 2.9 | DICOM calibrated |
| luminance | 500cd/m² |
Table 2 General Comparison of C53S+, C53SP+
10
510(k) Submission
| 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 | - |
| 3.3 | Dot Clock | 285 MHz | 285 MHz | - |
11
510(k) Submission
| 4 | Power Related Specifications | |||
|---|---|---|---|---|
| 4.1 | Power Requirements | DC 12V, 6.67A | AC 100-240V, 50/60Hz | Difference between built-in |
| power supply and built-out | ||||
| power supply | ||||
| 4.2 | Power Consumption / | |||
| Save Mode | 80W | |||
| Less than 5W | 95W | |||
| Less than 1W | Compared with the predicate | |||
| device, the proposed device | ||||
| consumes less power in the | ||||
| operating mode and more | ||||
| power in the power saving | ||||
| mode. | ||||
| 4.3 | Power Management | DVI DPMS, | ||
| DisplayPort 1.2 | DVI DMPM, | |||
| DisplayPort 1.2a | Different design scheme | |||
| 5 | Miscellaneous Features/Specifications | |||
| 5.1 | QC software | Beacon Monitor Manage | QA Medivisor / Medivisor | |
| NXF-CAL | Different design scheme | |||
| 5.2 | Sensors | Built-in Front Sensor (only for | ||
| C53SP+) | ||||
| 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 | 1 upstream, | ||
| 2 downstream / Rev. 2.0 | 1 upstream, | |||
| 2 downstream / Rev. 2.0 | - | |||
| 5.4 | Dimensions w/o stand | |||
| (W x H x D) | 395.3 x 549.6/629.6 x 234.8 | |||
| mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to | ||
| the different panel size |
12
| 5M LCD Monitors C53S+, C53SP+, G53S+, G53SP+ | ||
|---|---|---|
| -- | -- | ---------------------------------------------- |
| ID | Comparison
Item | Proposed Device
5MP Monochrome LCD
Monitors G53S+, G53SP+ | 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(2048 X 2560) | 5MP(2048 X 2560) | - |
| 2.4 | Aspect ratio | 4:5 | 4:5 | - |
| 2.5 | Display Area | Horizontal: 337.92mm
Vertical: 422.4mm | 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 | - |
Table 3 General Comparison of G53S+/G53SP+
13
510(k) Submission
| 2.9 | DICOM calibrated
luminance | 500cd/m² | 1,000cd/m² | The luminance ratio (max/min)
between 250 and 650 generally
recommended taking account
of the contrast sensitivity of
human eyes is available in the
proposed devices. Beacon
does not see merits of the
extremely high luminance
offering contrast beyond what
the eyes can see. |
|------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | - |
14
510(k) Submission
| 3.2 | Scanning Frequency
(H, V) | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | |
|-----|---------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 3.3 | Dot Clock | 285 MHz | 285 MHz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC 12V, 6.67A | AC 100-240V, 50/60Hz | Difference between built-in
power supply and built-out
power supply |
| 4.2 | Power Consumption /
Save Mode | 80W
Less than 5W | 80W
Less than 1W | Compared with the predicate
device, the proposed device
consumes more power in the
power saving mode. |
| 4.3 | Power Management | DVI DPMS,
DisplayPort 1.2 | DVI DMPM,
DisplayPort 1.2a | Different design scheme |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor Manage | QA Medivisor / Medivisor
NXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor (only for
G53SP+)
Built-in Ambient Light Sensor
Built-in backlight sensor | Built-in Front Sensor
Built-in Ambient Light Sensor | Different design scheme |
15
510(k) Submission
| 5.3 | USB Ports/Standard | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | - |
|-----|-------------------------------------|----------------------------------------|----------------------------------------|-------------------------------------------------------------|
| 5.4 | Dimensions w/o stand
(W x H x D) | 395.3 x 549.6/ 629.6 x 234.8 mm | 361.5 x 517/612 x 196.5 mm | Different housing design due to
the different panel size |
16
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C53S+, C53SP+, G53S+, G53SP+.
8.3 Performance Testing
The bench tests were performed on C53S+, C53SP+, G53S+, G53SP+ 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℃ and 40℃ on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the luminance at the angles of 300 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
- Measure pixel fill factor like pixel structure and aperture ratio etc.
17
The test results showed that C53S+, C53SP+, G53S+, G53SP+ 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 C53S+, C53SP+, G53S+, G53SP+.
9. 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:
- The intended use of C53S+, C53SP+, G53S+, G53SP+ is totally same as that of the predicate devices.
- The technological characteristics differences between C53S+, C53SP+, G53S+, G53SP+ 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 C53S+, C53SP+, G53S+, G53SP+ are equivalent to those of the predicate devices.
18
006_Indications for Use Statement
19
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200864
Device Name
5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+
Indications for Use (Describe)
The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ 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.
| l ype of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|
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