(20 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the devices (2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+) are primarily established through performance testing against the AAPM Task Group 18 (TG18) guideline and comparison with predicate devices.
| Acceptance Criteria (Bench Tests per TG18 guideline and comparison to predicate) | Reported Device Performance | Comments |
|---|---|---|
| Conformance to DICOM GSDF | Verified | The test results showed conformance. |
| Luminance non-uniformity characteristics | Measured and found acceptable | The test results showed proper performance. |
| Chromaticity non-uniformity characteristics | Measured and found acceptable | The test results showed proper performance. |
| Chromaticity at the center of the display screen at 5%, 50%, and 95% of maximum luminance | Measured and found acceptable | The test results showed proper performance. |
| Presence or absence of miscellaneous artifacts on the display screen | Visually checked and found acceptable | The test results showed proper performance. |
| Spatial resolution (MTF) | Measured and found acceptable | The test results showed proper performance. |
| Maximum number allowed for each type of pixel defects/faults | Measured and found acceptable | The test results showed proper performance. |
| Equivalence to predicate devices in display characteristics | Demonstrated | The devices' display characteristics were found equivalent to predicate devices, with differences not affecting observer performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size for the test set. It mentions "bench tests were performed on C22S+, C22SP+, G22SP+, G22SP+, G23SP+" for multiple devices (six models in total). It implies one or more units of each model were tested.
The data provenance is not explicitly stated. However, since the submitter is Shenzhen Beacon Display Technology Co., Ltd. in China, it is highly likely that the testing was conducted in China or under their direct supervision. The study appears to be retrospective as it's a premarket notification for devices seeking substantial equivalence to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The acceptance criteria relate to technical performance specifications of the monitors themselves (e.g., luminance, resolution), not diagnostic accuracy based on expert interpretation of medical images displayed on them. Therefore, there's no mention of experts establishing a ground truth for diagnostic accuracy in this context.
4. Adjudication Method for the Test Set
This information is not applicable as the described tests are technical performance evaluations of the monitors, not diagnostic studies requiring expert adjudication of image interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The devices are medical monitors, not AI algorithms, so this type of study is not relevant to their regulatory clearance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. The devices are medical monitors, which display images for human interpretation, they are not algorithms.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on technical specifications and measurable performance according to established industry standards, specifically the AAPM Task Group 18 (TG18) guideline for assessing display performance for medical imaging systems. This involves quantifiable measurements of display characteristics rather than clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. As these are medical display monitors, there is no "training set" in the context of machine learning or AI algorithms. The monitors are hardware devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for these devices.
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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
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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
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006_Indications for Use Statement
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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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007_510 (k) Summary
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)] 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, NanshanDistrict, 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)]
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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.
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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°CHumidity: 15% ~ 85% |
| Storage temperature and humidity | Temperature: -20°C ~ 60°CHumidity: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 |
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| 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) |
| Operatingtemperature and | Temperature: 0°C ~ 40°CHumidity: 15% ~ 85% |
| Storage temperatureand humidity | Temperature: -20°C ~ 60°CHumidity: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) (withpacking) |
| Weight | 8.0 ± 0.5 kg (Net)11.0 ± 0.5 kg (Gross) |
| Operating temperature and humidity | Temperature: 0°C ~ 40°CHumidity: 15% ~ 85% |
| Storage temperature and humidity | Temperature: -20°C ~ 60°CHumidity:10% ~ 90% |
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8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended use:
| ID | Comparison Item | Proposed Device2MP Color LCD Monitors(C22S+, C22SP+) | Predicate Device2MP Color LCD Monitor(RX250, RX250-AR) |
|---|---|---|---|
| 1 | Intended Use | The 2MP LCD MonitorsC22S+, C22SP+ are intendedto be used in displaying andviewing digital images forreview, analysis and diagnosisby trained medicalpractitioners. The monitors donot support the display ofmammography images fordiagnosis. | This product is intended to beused in displaying and viewingdigital images for review, analysisand diagnosis by trainedmedical practitioners. It does notsupport the display ofmammography images fordiagnosis. |
Table 1 Intended Use Comparison of C22S+/C22SP+
Table 2 Intended Use Comparison of G22S+, G22SP+, G23S+, G23SP+
| ID | Comparisonltem | Proposed Device2MP Monochrome LCDMonitors(G22S+, G22SP+, G23S+,G23SP+) | Predicate Device2MP Monochrome LCDMonitor(RadiForce GX240) |
|---|---|---|---|
| 1 | Intended Use | The 2MP LCD MonitorsG22S+, G22SP+, G23S+,G23SP+ are intended to beused in displaying and viewingdigital images for review,analysis and diagnosis bytrained medicalpractitioners.The monitors donot support the display ofmammography images fordiagnosis. | The RadiForce GX240 isintended to be used in displayingand viewing digital images bytrained medical practitioners. TheRadiForce GX240 does notsupport the display ofmammography images fordiagnosis. |
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8.2 Comparison table
| Table 3 General Comparison of C22S+/C22SP+ |
|---|
| --------------------------------------------- |
| ID | ComparisonItem | Proposed Device2MP Color LCDMonitors(C22S+, C22SP+) | Predicate Device2MP Color LCDMonitor(RX250, RX250-AR) | Explanation ofDifference |
|---|---|---|---|---|
| 2 | Display Performance/Specifications | |||
| 2.1 | ScreenTechnology | IPS TFT Color LCDPanel | IPS TFT Color LCDPanel | - |
| 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 screensize | 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 | Typicalluminance | 1000 cd/m² | 800 cd/m² | Different screen |
| 2.8 | DICOMcalibratedluminance | 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 1.07billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors | From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors | Different screen |
| 2.12 | Luminancenon-uniformitycompensation | - | Digital UniformityEqualizer | Different designscheme |
| 3 | Video Signals | |||
| 3.1 | Input videosignals | DVI-D x 1,DisplayPort x 1,VGA x 1 | DVI-D x 1,DisplayPort x 1 | Different designscheme |
| 3.2 | Ouput videosignals | - | - | - |
| 3.3 | ScanningFrequency (H,V) | 31 - 82 kHz / 59 - 61HzFrame synchronousmode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61Hz(VGA Text: 69 - 71Hz)Frame synchronousmode: 59 - 61 Hz | - |
| 4 | Power Related Specifications | |||
| 4.1 | PowerRequirements | DC 12 V/6.0 A | AC 100 - 240 V: 50 /60Hz | Differencebetween Built-inpower supplyand Built-outpower supply |
| 4.2 | PowerConsumption /Save Mode | 60 W/Less than 5 W | 79 W / Less than 1.6W | Different designscheme |
| 4.3 | PowerManagement | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | - |
| 5 | Miscellaneous Features/Specifications | |||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Different designscheme |
| 5.2 | Sensors | C22S+:Backlight Sensor,Ambient Light SensorC22SP+:Backlight Sensor,Ambient Light SensorIntegrated FrontSensor | Backlight Sensor,Presence Sensor | Different designscheme |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream / Rev.2.0 | 1 upstream,2 downstream / Rev.2.0 | - |
| 5.4 | Dimensionsw/o stand (W xH x D) | 365 x 478 x 75 mm | 361 x 465 x 78 mm | Different housingdesign due to thedifferent panelsize |
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Table 4 General Comparison of G22S+/G22SP+
| ID | ComparisonItem | Proposed Device2MP MonochromeLCD Monitors(G22S+, G22SP+) | Predicate Device2MP MonochromeLCD Monitor(RadiForce GX240) | Explanation ofDifference | |
|---|---|---|---|---|---|
| 2 | Display Performance/Specifications | ||||
| 2.1 | ScreenTechnology | Monochrome TFTLCD Panel (IPS) | Monochrome TFTLCD 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 screensize | 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 | Typicalluminance | 2000 cd/m² | 1200 cd/m² | Different screen | |
| 2.8 | DICOMcalibratedluminance | 500 cd/m² | 500 cd/m² | - | |
| 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | |
| 2.10 | Backlighting | LED | LED | - | |
| 2.11 | GrayscaleTones | 10-bit (DisplayPort):1,024 from a palette of1,024 tones8-bit: 256 from apalette of 1,024 tones | 10-bit (DisplayPort):1,024 from a palette of16,369 tones8-bit: 256 from apalette of 16,369tones | Different screen | |
| 2.12 | Luminancenon-uniformitycompensation | - | Digital UniformityEqualizer | Different designscheme | |
| 3 | Video Signals | ||||
| 3.1 | Input videosignals | DVI-D x 1,DisplayPort x 1,VGA x 1 | DVI-D x 1,DisplayPort x 1 | Different designscheme | |
| 3.2 | Ouput videosignals | - | DisplayPort x 1 (daisychain) | Different designscheme | |
| 3.3 | ScanningFrequency (H,V) | 31 - 82 kHz / 59 - 61HzFrame synchronousmode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61HzFrame synchronousmode: 59 - 61 Hz | ||
| 4 | Power Related Specifications | ||||
| 4.1 | PowerRequirements | DC 12 V/6.0 A | AC 100 -120 V, 200 -240 V: 50 / 60Hz | Differencebetween Built-inpower supplyand Built-outpower supply | |
| 4.2 | PowerConsumption /Save Mode | 50 W/Less than 5 W | 76 W / Less than 1.6W | Different designscheme | |
| 4.3 | PowerManagement | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | ||
| 5 | Miscellaneous Features/Specifications | ||||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Different designscheme | |
| 5.2 | Sensors | G22S+:Backlight Sensor,Ambient Light SensorG22SP+:Backlight Sensor,Ambient Light SensorIntegrated FrontSensor | Backlight Sensor,Presence Sensor,Integrated FrontSensorAmbient Light Sensor | Different designscheme | |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream | 1 upstream,2 downstream | - | |
| 5.4 | Dimensionsw/o stand (W xH x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housingdesign due to thedifferent panelsize |
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Table 5 General Comparison of G23S+/G23SP+
| ID | ComparisonItem | Proposed Device2MP MonochromeLCD Monitors(G23S+, G23SP+) | Predicate Device2MP MonochromeLCD Monitor(RadiForce GX240) | Explanation ofDifference | |
|---|---|---|---|---|---|
| 2 | Display Performance/Specifications | ||||
| 2.1 | ScreenTechnology | Monochrome TFTLCD Panel (IPS) | Monochrome TFTLCD 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 screensize | 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 | Typicalluminance | 1900 cd/m² | 1200 cd/m² | Different screen | |
| 2.8 | DICOMcalibratedluminance | 500 cd/m² | 500 cd/m² | ||
| 2.9 | Contrast ratio | 1800:1 | 1400 : 1 | Different screen | |
| 2.10 | Backlighting | LED | LED | ||
| 2.11 | GrayscaleTones | 10-bit (DisplayPort):1,024 from a palette of1,024 tones8-bit: 256 from apalette of 1,024 tones | 10-bit (DisplayPort):1,024 from a palette of16,369 tones8-bit: 256 from apalette of 16,369tones | Different screen | |
| 2.12 | Luminancenon-uniformitycompensation | Digital UniformityEqualizer | Different designscheme | ||
| 3 | Video Signals | ||||
| 3.1 | Input videosignals | DVI-D x 1,DisplayPort x 1,VGA x 1 | DVI-D x 1,DisplayPort x 1 | Different designscheme | |
| 3.2 | Ouput videosignals | - | DisplayPort x 1 (daisychain) | Different designscheme | |
| 3.3 | ScanningFrequency (H,V) | 31 - 82 kHz / 59 - 61HzFrame synchronousmode: 59 - 61 Hz | 31 - 100 kHz / 59 - 61HzFrame synchronousmode: 59 - 61 Hz | ||
| 4 | Power Related Specifications | ||||
| 4.1 | PowerRequirements | DC 12 V/6.0 A | AC 100 –120 V, 200 -240 V: 50 / 60Hz | Differencebetween Built-inpower supplyand Built-outpower supply | |
| 4.2 | PowerConsumption /Save Mode | 50 W/Less than 5 W | 76 W / Less than 1.6W | Different designscheme | |
| 4.3 | PowerManagement | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | ||
| 5 | Miscellaneous Features/Specifications | ||||
| 5.1 | QC software | Beacon MonitorManage | RadiCS | Different designscheme | |
| 5.2 | Sensors | G23S+:Backlight Sensor,Ambient Light SensorG23SP+:Backlight Sensor,Ambient Light SensorIntegrated FrontSensor | Backlight Sensor,Presence Sensor,Integrated FrontSensorAmbient LightSensor | Different designscheme | |
| 5.3 | USBPorts/Standard | 1 upstream,2 downstream | 1 upstream,2 downstream | - | |
| 5.4 | Dimensionsw/o stand (W xH x D) | 365 x 478 x 75 mm | 376 x 505 x 98 mm | Different housingdesign due to thedifferent panelsize |
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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
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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.
§ 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).