(20 days)
Not Found
No
The summary describes a medical display monitor and its technical specifications, focusing on image quality and adherence to standards like DICOM. There is no mention of AI, ML, or any features that would suggest the device performs algorithmic analysis or interpretation of images.
No
The device is a medical image display monitor, used for viewing and diagnosis, not for providing therapy.
No
The device is a medical monitor intended for displaying images for review, analysis, and diagnosis by medical practitioners; it does not perform the diagnosis itself.
No
The device description clearly states it is a 21.3-inch TFT LCD color/grayscale monitor, which is a hardware device. The performance studies also focus on hardware characteristics like luminance, chromaticity, and spatial resolution.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners." This describes a device used for interpreting medical images, which are typically generated from imaging modalities like X-rays, CT scans, or MRIs.
- Device Description: The description focuses on the technical specifications of a medical display monitor designed for general radiography. It mentions meeting DICOM standards and providing high-definition image outputs.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to obtain information about a patient's health. IVDs are specifically designed for this purpose.
The device is clearly a medical imaging display monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/grayscale monitors. They are specifically designed to provide the high definition image outputs for general Radiography.
The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ 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 acryl glass, 2 means 2MP; 2 or 3 means a screen change. For example, C22S+ is a color LCD monitor; G22SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen, and G23SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen which is different with that of G22SP+.
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
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 C22S+, C22SP+, G22SP+, G22SP+, G23SP+ 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 guideline).
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
The test results showed that C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are with display characteristics equivalent to those of the predicate device. RadiForce RX250 and RX250-AR, and RadiForce GX240 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Shenzhen Beacon Display Technology Co., Ltd. % Fu Ailing Document Engineer 12F, Block Bl, NanshanZhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA
Re: K201599
Trade/Device Name: 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+ G2SP+, G23S+,G23SP+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: May 29, 2020 Received: June 12, 2020
July 2, 2020
Dear Fu 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
006_Indications for Use Statement
3
4
Indications for Use
510(k) Number (if known)
Device Name
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
Indications for Use (Describe)
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.
| 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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5
007_510 (k) Summary
6
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)] K201599
May 29, 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: | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+,
G22SP+, G23S+, G23SP+ |
|-----------------------|---------------------------------------------------------------------------------|
| Common Name: | 2MP LCD Monitors C22S+, C22SP+, G22S+, G22SP+, G23S+,
G23SP+ |
| 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)]
7
The identified predicates within this submission are as follows:
EIZO Corporation, 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR has been cleared by FDA through 510(k) No. K160247 (Decision Date - February 23, 2016).
EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012).
5. Description of the Device [21 CFR 807.92(a) (4)]
C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/ grayscale monitors. They are specifically designed to provide the high definition image outputs for general Radiography.
The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ 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 acryl glass, 2 means 2MP; 2 or 3 means a screen change. For example, C22S+ is a color LCD monitor; G22SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen, and G23SP+ is a monochrome LCD monitor with the additional acryl glass on the front of the screen which is different with that of G22SP+.
6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.
8
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
|---|---|
| Brightness (Typ.) | 1000 cd/m² |
| CR (Typ.) | 1800:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
| Native resolution | 1,200 x 1,600 |
| Display area | 324 mm(H) x 432 mm (V) |
| Aspect ratio | 3:4 |
| Screen size | 21.3" real diagonal |
| Power | DC 12 V/6.0 A |
| Power consumption | Max. 60 W |
| Input signals | DVI-D, Display Port, VGA |
| Plug and play | VESA DDC 2B |
| Dimension | 369 mm (W) x 511.15 ~ 596.15 mm (H) x 220 mm (D) |
| (with stand) | |
| 608 x 561 x 327 mm (with packing) | |
| Weight | 8.0 ± 0.5 kg (Net) |
| 11.0 ± 0.5 kg (Gross) | |
| Operating temperature and | Temperature: 0°C ~ 40°C |
| Humidity: 15% ~ 85% | |
| Storage temperature and humidity | Temperature: -20°C ~ 60°C |
| Humidity:10% ~ 90% |
C22S+/C22SP+ Color LCD monitor
G22S+/G22SP+ Monochrome LCD monitor
| Panel | 21.3", TFT, monochrome, LCD screen, anti-glare, |
|---|---|
| Brightness (Typ.) | 2000 cd/m² |
| CR (Typ.) | 1800:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
| Native resolution | 1,200 x 1,600 |
| Display area | 324 mm(H) x 432 mm (V) |
| Aspect ratio | 3:4 |
| Screen size | 21.3" real diagonal |
9
| Power | DC 12 V/6.0 A |
|---|---|
| Power consumption | Max. 50 W |
| Input signals | DVI-D, Display Port, VGA |
| Plug and play | VESA DDC 2B |
| Dimension | 369 x 511.5 ~ 596.15 x 220 mm (with stand) |
| 608 x 561 x 327 mm (with packing) | |
| Weight | 8.0 ± 0.5 kg (Net) |
| 11.0 ± 0.5 kg (Gross) | |
| Operating | |
| temperature and | Temperature: 0°C ~ 40°C |
| Humidity: 15% ~ 85% | |
| Storage temperature | |
| and humidity | Temperature: -20°C ~ 60°C |
| Humidity:10% ~ 90% |
G23S+/G23SP+ Monochrome LCD monitor
| Panel | 21.3", TFT, monochrome, LCD screen, anti-glare, |
|---|---|
| Brightness (Typ.) | 1900 cd/m² |
| CR (Typ.) | 1800:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
| Native resolution | 1,200 x 1,600 |
| Display area | 324 mm(H) x 432 mm (V) |
| Aspect ratio | 3:4 |
| Screen size | 21.3" real diagonal |
| Power | DC 12 V/6.0 A |
| Power consumption | Max. 50 W |
| Input signals | DVI-D, Display Port, VGA |
| Plug and play | VESA DDC 2B |
| Dimension | 369 mm (W) x 511.5 ~ 596.15 mm (H) x 220 mm (D) |
| (with stand) | |
| 608 mm (W) x 561 mm (H) x 327 mm (D) (with | |
| packing) | |
| Weight | 8.0 ± 0.5 kg (Net) |
| 11.0 ± 0.5 kg (Gross) | |
| Operating temperature and humidity | Temperature: 0°C ~ 40°C |
| Humidity: 15% ~ 85% | |
| Storage temperature and humidity | Temperature: -20°C ~ 60°C |
| Humidity:10% ~ 90% |
10
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended use:
| ID | Comparison Item | Proposed Device
2MP Color LCD Monitors
(C22S+, C22SP+) | Predicate Device
2MP Color LCD Monitor
(RX250, RX250-AR) |
|----|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitors
C22S+, C22SP+ are intended
to be used in displaying and
viewing digital images for
review, analysis and diagnosis
by trained medical
practitioners. The monitors do
not support the display of
mammography images for
diagnosis. | This product is intended to be
used in displaying and viewing
digital images for review, analysis
and diagnosis by trained
medical practitioners. It does not
support the display of
mammography images for
diagnosis. |
Table 1 Intended Use Comparison of C22S+/C22SP+
Table 2 Intended Use Comparison of G22S+, G22SP+, G23S+, G23SP+
| ID | Comparison
ltem | Proposed Device
2MP Monochrome LCD
Monitors
(G22S+, G22SP+, G23S+,
G23SP+) | Predicate Device
2MP Monochrome LCD
Monitor
(RadiForce GX240) |
|----|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitors
G22S+, G22SP+, G23S+,
G23SP+ are intended to be
used in displaying and viewing
digital images for review,
analysis and diagnosis by
trained medical
practitioners.The monitors do
not support the display of
mammography images for
diagnosis. | The RadiForce GX240 is
intended to be used in displaying
and viewing digital images by
trained medical practitioners. The
RadiForce GX240 does not
support the display of
mammography images for
diagnosis. |
11
8.2 Comparison table
| Table 3 General Comparison of C22S+/C22SP+ |
|---|
| --------------------------------------------- |
| ID | Comparison
Item | Proposed Device
2MP Color LCD
Monitors
(C22S+, C22SP+) | Predicate Device
2MP Color LCD
Monitor
(RX250, RX250-AR) | Explanation of
Difference |
|------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen
Technology | IPS TFT Color LCD
Panel | IPS TFT Color LCD
Panel | - |
| 2.2 | Viewing angle
(H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - |
| 2.5 | Active screen
size | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - |
| 2.7 | Typical
luminance | 1000 cd/m² | 800 cd/m² | Different screen |
| 2.8 | DICOM
calibrated
luminance | 500 cd/m² | 400 cd/m² | Different screen |
| 2.9 | Contrast ratio | 1800 : 1 | 1400 : 1 | Different screen |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Display Colors | From a palette of 1.07
billion colors:
- 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | From a palette of 68
billion colors: - 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | Different screen |
| 2.12 | Luminance
non-uniformity
compensation | - | Digital Uniformity
Equalizer | Different design
scheme |
| 3 | Video Signals | | | |
| 3.1 | Input video
signals | DVI-D x 1,
DisplayPort x 1,
VGA x 1 | DVI-D x 1,
DisplayPort x 1 | Different design
scheme |
| 3.2 | Ouput video
signals | - | - | - |
| 3.3 | Scanning
Frequency (H,
V) | 31 - 82 kHz / 59 - 61
Hz
Frame synchronous
mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61
Hz
(VGA Text: 69 - 71
Hz)
Frame synchronous
mode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | | | |
| 4.1 | Power
Requirements | DC 12 V/6.0 A | AC 100 - 240 V: 50 /
60Hz | Difference
between Built-in
power supply
and Built-out
power supply |
| 4.2 | Power
Consumption /
Save Mode | 60 W/Less than 5 W | 79 W / Less than 1.6
W | Different design
scheme |
| 4.3 | Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor
Manage | RadiCS | Different design
scheme |
| 5.2 | Sensors | C22S+:
Backlight Sensor,
Ambient Light Sensor
C22SP+:
Backlight Sensor,
Ambient Light Sensor
Integrated Front
Sensor | Backlight Sensor,
Presence 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) | 365 x 478 x 75 mm | 361 x 465 x 78 mm | Different housing
design due to the
different panel
size |
12
13
Table 4 General Comparison of G22S+/G22SP+
| ID | Comparison
Item | Proposed Device
2MP Monochrome
LCD Monitors
(G22S+, G22SP+) | Predicate Device
2MP Monochrome
LCD Monitor
(RadiForce GX240) | Explanation of
Difference | |
|------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--|
| 2 | | Display Performance/Specifications | | | |
| 2.1 | Screen
Technology | Monochrome TFT
LCD Panel (IPS) | Monochrome TFT
LCD Panel (IPS) | - | |
| 2.2 | Viewing angle
(H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen | |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - | |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - | |
| 2.5 | Active screen
size | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - | |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - | |
| 2.7 | Typical
luminance | 2000 cd/m² | 1200 cd/m² | Different screen | |
| 2.8 | DICOM
calibrated
luminance | 500 cd/m² | 500 cd/m² | - | |
| 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | |
| 2.10 | Backlighting | LED | LED | - | |
| | | | | | |
| 2.11 | Grayscale
Tones | 10-bit (DisplayPort):
1,024 from a palette of
1,024 tones
8-bit: 256 from a
palette of 1,024 tones | 10-bit (DisplayPort):
1,024 from a palette of
16,369 tones
8-bit: 256 from a
palette of 16,369
tones | Different screen | |
| 2.12 | Luminance
non-uniformity
compensation | - | Digital Uniformity
Equalizer | Different design
scheme | |
| 3 | Video Signals | | | | |
| 3.1 | Input video
signals | DVI-D x 1,
DisplayPort x 1,
VGA x 1 | DVI-D x 1,
DisplayPort x 1 | Different design
scheme | |
| 3.2 | Ouput video
signals | - | DisplayPort x 1 (daisy
chain) | Different design
scheme | |
| 3.3 | Scanning
Frequency (H,
V) | 31 - 82 kHz / 59 - 61
Hz
Frame synchronous
mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61
Hz
Frame synchronous
mode: 59 - 61 Hz | | |
| 4 | Power Related Specifications | | | | |
| 4.1 | Power
Requirements | DC 12 V/6.0 A | AC 100 -120 V, 200 -
240 V: 50 / 60
Hz | Difference
between Built-in
power supply
and Built-out
power supply | |
| 4.2 | Power
Consumption /
Save Mode | 50 W/Less than 5 W | 76 W / Less than 1.6
W | Different design
scheme | |
| 4.3 | Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | | |
| 5 | Miscellaneous Features/Specifications | | | | |
| 5.1 | QC software | Beacon Monitor
Manage | RadiCS | Different design
scheme | |
| 5.2 | Sensors | G22S+:
Backlight Sensor,
Ambient Light Sensor
G22SP+:
Backlight Sensor,
Ambient Light Sensor
Integrated Front
Sensor | Backlight Sensor,
Presence Sensor,
Integrated Front
Sensor
Ambient Light Sensor | Different design
scheme | |
| 5.3 | USB
Ports/Standard | 1 upstream,
2 downstream | 1 upstream,
2 downstream | - | |
| 5.4 | Dimensions
w/o stand (W x
H x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housing
design due to the
different panel
size | |
14
15
Table 5 General Comparison of G23S+/G23SP+
| ID | Comparison
Item | Proposed Device
2MP Monochrome
LCD Monitors
(G23S+, G23SP+) | Predicate Device
2MP Monochrome
LCD Monitor
(RadiForce GX240) | Explanation of
Difference | |
|------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--|
| 2 | | Display Performance/Specifications | | | |
| 2.1 | Screen
Technology | Monochrome TFT
LCD Panel (IPS) | Monochrome TFT
LCD Panel (IPS) | - | |
| 2.2 | Viewing angle
(H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Different screen | |
| 2.3 | Resolution | 2MP (1,200 x 1,600) | 2MP (1,200 x 1,600) | - | |
| 2.4 | Aspect ratio | 3 : 4 | 3 : 4 | - | |
| 2.5 | Active screen
size | 324.0 mm x 432.0 mm | 324.0 mm x 432.0 mm | - | |
| 2.6 | Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | - | |
| 2.7 | Typical
luminance | 1900 cd/m² | 1200 cd/m² | Different screen | |
| 2.8 | DICOM
calibrated
luminance | 500 cd/m² | 500 cd/m² | | |
| 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | |
| 2.10 | Backlighting | LED | LED | | |
| 2.11 | Grayscale
Tones | 10-bit (DisplayPort):
1,024 from a palette of
1,024 tones
8-bit: 256 from a
palette of 1,024 tones | 10-bit (DisplayPort):
1,024 from a palette of
16,369 tones
8-bit: 256 from a
palette of 16,369
tones | Different screen | |
| 2.12 | Luminance
non-uniformity
compensation | | Digital Uniformity
Equalizer | Different design
scheme | |
| 3 | Video Signals | | | | |
| 3.1 | Input video
signals | DVI-D x 1,
DisplayPort x 1,
VGA x 1 | DVI-D x 1,
DisplayPort x 1 | Different design
scheme | |
| 3.2 | Ouput video
signals | - | DisplayPort x 1 (daisy
chain) | Different design
scheme | |
| 3.3 | Scanning
Frequency (H,
V) | 31 - 82 kHz / 59 - 61
Hz
Frame synchronous
mode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61
Hz
Frame synchronous
mode: 59 - 61 Hz | | |
| 4 | Power Related Specifications | | | | |
| 4.1 | Power
Requirements | DC 12 V/6.0 A | AC 100 –120 V, 200 -
240 V: 50 / 60
Hz | Difference
between Built-in
power supply
and Built-out
power supply | |
| 4.2 | Power
Consumption /
Save Mode | 50 W/Less than 5 W | 76 W / Less than 1.6
W | Different design
scheme | |
| 4.3 | Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | | |
| 5 | Miscellaneous Features/Specifications | | | | |
| 5.1 | QC software | Beacon Monitor
Manage | RadiCS | Different design
scheme | |
| 5.2 | Sensors | G23S+:
Backlight Sensor,
Ambient Light Sensor
G23SP+:
Backlight Sensor,
Ambient Light Sensor
Integrated Front
Sensor | Backlight Sensor,
Presence Sensor,
Integrated Front
Sensor
Ambient Light
Sensor | Different design
scheme | |
| 5.3 | USB
Ports/Standard | 1 upstream,
2 downstream | 1 upstream,
2 downstream | - | |
| 5.4 | Dimensions
w/o stand (W x
H x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housing
design due to the
different panel
size | |
16
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C22S+, G22S+, G22S+, G22SP+, G23S+, G23SP+.
8.3 Performance Testing
The bench tests were performed on C22S+, C22SP+, G22SP+, G22SP+, G23SP+ 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 guideline).
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance.
- Visually check the presence or absence of miscellaneous artifacts on the display
18
screen in accordance with TG18 guideline.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
The test results showed that C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are with display characteristics equivalent to those of the predicate device. RadiForce RX250 and RX250-AR, and RadiForce GX240 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+.
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 uses of C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are totally same as those of the predicate devices.
- The technological characteristics differences between C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ and RadiForce RX250 and RX250-AR, RadiForce GX240 do not affect the safety and effectiveness, so no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C22S+, C22SP+, G22S+, G22SP+, G23S+, G23SP+ are equivalent to those of the predicate devices.