(39 days)
Not Found
No
The device description and performance studies focus solely on the display characteristics and conformance to medical imaging display standards (like DICOM GSDF and TG18 guidelines). There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No
The device is a medical monitor intended for displaying and viewing digital images for review, analysis, and diagnosis, not for providing therapy.
No
This device is a medical monitor intended for displaying and viewing digital images. It is used by medical practitioners for review, analysis, and diagnosis, but the monitor itself does not perform any diagnostic analysis; it merely presents the images.
No
The device description explicitly states it is an LCD monitor, which is a hardware component. 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:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device function: The description clearly states that this device is a monitor intended for displaying and viewing digital images for review, analysis, and diagnosis. It does not perform any tests on biological samples.
- Intended Use: The intended use is focused on the visual interpretation of medical images, not on analyzing biological specimens.
Therefore, this device falls under the category of medical imaging display devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) 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.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.
Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.
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 G22S+, G22SP+, C22S+, C22SP+ 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 G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device, RadiForce GX240, RadiForce RX250 and RX250-AR 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 contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2017
Shenzhen Beacon Display Technology Co., Ltd. % Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen Guangdong 518055 CHINA
Re: K172815
Trade/Device Name: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 29, 2017 Received: September 18, 2017
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Oels
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K172815
Device Name
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
Indications for Use (Describe)
The 2MP LCD Monitor (G22S+, G22S+, C22S+, C22SP+) 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.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
August 29, 2017
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.: | +86-0755-33985118-5150 | |
| 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 LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) Common Name: 2MP LCD Monitor 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 predicates within this submission are as follows: EIZO NANAO Corporation, 2MP Monochrome LCD Monitor, RadiForce GX240 has been cleared by FDA through 510(k) No. K120407 (Decision Date - April 19, 2012).
4
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).
5. Description of the Device [21 CFR 807.92(a) (4)]
Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.
Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.
6. Intended Use [21 CFR 807.92(a)(5)]
The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 21.3", TFT, monochrome, LCD screen, anti-glare,
hard coating |
|-------------------|-----------------------------------------------------------------|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 270 × (V) 0.270 mm |
G22S+/G22SP+ Monochrome LCD monitor
5
| 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. 40 W | |
| Input signals | DVI-D, Display Port, VGA | |
| Plug and play | VESA DDC 2B | |
| Dimension | 369 mm (W) x 506 ~ 626 mm (H) x 235 mm (D) (with stand) | |
| 369 mm (W) x 483 mm (H) x 65 mm (D) (without stand) | ||
| Weight | 6.0 kg (without Stand) | |
| 9.2 kg (with Stand) | ||
| Operating | ||
| temperature and | ||
| humidity | Temperature: 5°C ~ 35°C | |
| Humidity: 15% ~ 85% | ||
| Storage temperature | ||
| and humidity | Temperature: -20°C ~ 60°C | |
| Humidity:10% ~ 90% |
C22S+/C22SP+ Color LCD monitor
| Panel | 21.3", TFT, color, LCD screen, anti-glare, hard coating |
|---|---|
| Brightness (Typ.) | 500 cd/m² |
| CR (Typ.) | 1400:1 |
| Viewing angle | R/L 176°, U/D 176° 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 |
6
| 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 506 ~ 626 mm (H) x 235 mm (D) (with | |
| stand) | ||
| 369 mm (W) x 483 mm (H) x 65 mm (D) (without | ||
| stand) | ||
| Weight | 6.0 kg (without Stand) | |
| 9.2 kg (with Stand) | ||
| Operating | ||
| temperature and | ||
| humidity | Temperature: 5°C ~ 35°C | |
| Humidity: 15% ~ 85% | ||
| Storage temperature | ||
| and humidity | Temperature: -20°C ~ 60°C | |
| Humidity:10% ~ 90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | Comparison
Item | Proposed Device
2MP Monochrome LCD
Monitor (G22S+, G22SP+) | Predicate Device
2MP Monochrome LCD
Monitor (RadiForce GX240) |
|----|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitor
(G22S+, G22SP+) 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. | 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. |
| Table 1 Intended Use Comparison of G22S+/G22SP+ | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -------------------------------------------------- |
7
| ID | Comparison Item | Proposed Device
2MP Color LCD Monitor
(C22S+, C22SP+) | Predicate Device
2MP Color LCD Monitor
(RX250, RX250-AR) |
|----|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended Use | The 2MP LCD Monitor (C22S+,
C22SP+) 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. | 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 2 Intended Use Comparison of C22S+/C22SP+
8.2 Comparison table
| ID | Comparison
Item | Proposed Device
2MP Monochrome
LCD Monitor (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: 176°, V: 176° | H: 176°, V: 176° | - |
| 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 | 1400:1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Grayscale Tones | 10-bit (DisplayPort):
1,024 from a palette of 16,369 tones
8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort):
1,024 from a palette of 16,369 tones
8-bit: 256 from a palette of 16,369 tones | - |
| 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 - 100 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 | 40 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) | 369 x 483 x 65 mm | 376 x 505 x 98 mm | Different housing
design due to the
different panel
size |
Table 3 General Comparison of G22S+/G22SP+
8
9
Table 4 General Comparison of C22S+/C22SP+
| ID | Comparison
Item | Proposed Device
2MP Color LCD
Monitor (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: 176°, V: 176° | H: 176°, V: 176° | - |
| 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 | 900 cd/m² | 800 cd/m² | Different screen |
| 2.8 | DICOM
calibrated
luminance | 500 cd/m² | 400 cd/m² | Different screen |
| 2.9 | Contrast ratio | 1400 : 1 | 1400 : 1 | - |
| 2.10 | Backlighting | LED | LED | - |
| 2.11 | Display Colors | From a palette of 68
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 | - |
| 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 - 100 kHz / 59 - 61
Hz
(VGA Text: 69 - 71 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) | 369 x 483 x 65 mm | 361 x 465 x 78 mm | Different housing
design due to the
different panel
size |
10
11
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the G22S+, G22SP+, C22S+, C22SP+.
8.3 Performance Testing
The bench tests were performed on G22S+, G22SP+, C22S+, C22SP+ 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.
12
- 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 G22S+, G22SP+, C22S+, C22SP+ are with display characteristics equivalent to those of the predicate device, RadiForce GX240, RadiForce RX250 and RX250-AR except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for G22S+, G22SP+, C22S+, C22SP+.
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 G22S+, G22SP+, C22S+, C22SP+ is totally same as that of the ● predicate device.
- The technological characteristics differences between G22S+, G22SP+, C22S+, C22SP+ and RadiForce GX240, RadiForce RX250 and RX250-AR do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of G22S+, G22SP+, C22S+, C22SP+ are equivalent to those of the predicate device.