(48 days)
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.
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.
The document describes the premarket notification (510(k)) for Shenzhen Beacon Display Technology Co., Ltd.'s 5MP Color and Monochrome LCD Monitors (C53S+, C53SP+, G53S+, G53SP+). However, this document does not contain information about an AI/algorithm-driven device, nor does it detail a study proving adherence to specific acceptance criteria for such a device in the context of AI model performance. Instead, it focuses on the substantial equivalence of the monitors to a predicate device, primarily through bench testing of display characteristics.
Therefore, I cannot provide the requested information as it pertains to an AI/algorithm efficacy study, acceptance criteria for an AI model, sample sizes, expert involvement, or MRMC studies, because this document is about medical display monitors and their technical specifications, not an AI software or algorithm.
The document states:
- Device Type: 5MP Color LCD Monitors C53S+, C53SP+; 5MP Monochrome LCD Monitors G53S+, G53SP+. These are hardware display devices, not AI algorithms.
- Intended Use: "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." This reinforces that the device is a display and not an AI component.
- Performance Testing: The "Performance Testing" section (page 16) outlines the tests conducted on the monitors themselves, such as "conformance to DICOM GSDF," "calibrated luminance," "luminance non-uniformity," "chromaticity non-uniformity," "temporal response," "spatial noise," "reflection coefficient," "veiling glare," and "spatial resolution." These are all standard display performance tests.
- No clinical or animal testing: The document explicitly states "No animal or clinical testing is needed for C53S+, C53SP+, G53S+, G53SP+." This further confirms that no studies involving human or animal subjects (which would be typical for evaluating an AI's impact on diagnostic performance) were conducted or required.
The request's parameters (acceptance criteria for an AI model, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the content of this document.
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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 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
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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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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, 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: 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:
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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)]
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| 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 | < 5 W |
| Control and connection : | |
| Front | 1 operation LED, 6 functional keys |
| Back | Ground1 Power switch1 DVI-D1 DP1 RJ451 USB Upstream Port1 USB Downstream Port*2 |
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| Mechanical characteristics : | |
|---|---|
| Housing components | Plastic+Metal |
| Ventilation openings | Natural heat radiation |
| Protection level | IP 20IP 65 (Applicable to the front panel of C53SP+) |
| Climatic conditions : | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Working atmospheric pressure | 700 hPa - 1060 hPa |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Transport and storage atmospheric pressure | 700 hPa - 1060 hPa |
| Safety regulations : | |
| Safety standards | IEC60601-1, EN60601-1ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1CAN/CSA-C22.2 NO. 60601-1:14 |
| Conformity | CCC, CE, TUV, FCC |
| Dimension: | |
| Dimensions (W x H x D) in mm | 395.3 x 549.6 ~ 629.6 x 234.8 mm |
| With packing (W x H x D) | 608 x 561 x 327 mm |
| Weight : | |
| Net weight | $9.5 \pm 0.5$ kg |
| Gross weight | $13.0 \pm 0.5$ kg |
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| Monitor characteristics : | |
|---|---|
| Screen technology | 21.3", TFT, grayscale, 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 (typ.), 1600:1 (min.) |
| Viewing angle ( CR > 10 ) | Horizontal: 178° (typ.)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 | < 5 W |
| Control and connection : | |
| Front | 1 operation LED, 6 functional keys |
| Back | Ground1 Power switch1 DVI-D1 DP1 RJ451 USB Upstream Port1 USB Downstream Port*2 |
| G53S+, G53SP+ Monochrome LCD monitors | ||
|---|---|---|
| Mechanical characteristics : | ||
| Housing components | Plastic+Metal | |
| Ventilation openings | Natural heat radiation | |
| Protection level | IP 20IP 65 (Applicable to the front panel of G53SP+) | |
| Climatic conditions : | ||
| Working temperature | 0°C - 40°C | |
| Working humidity | 15% - 85% Relative humidity, no condensation | |
| Working atmospheric pressure | 700 hPa - 1060 hPa | |
| Transport and storage temperature | -20°C - 60°C | |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation | |
| Transport and storage atmospheric pressure | 700 hPa - 1060 hPa | |
| Safety regulations : | ||
| Safety standards | IEC60601-1, EN60601-1ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1CAN/CSA-C22.2 NO. 60601-1:14 | |
| Conformity | CCC, CE, TUV, FCC | |
| Dimension: | ||
| Dimensions (W x H x D) in mm | 395.3 x 549.6 ~ 629.6 x 234.8 mm | |
| With packing (W x H x D) | 608 x 561 x 327 mm | |
| Weight : | ||
| Net weight | 9.5 ± 0.5 kg | |
| Gross weight | 13.0 ± 0.5 kg |
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8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison of C53S+, C53SP+, G53S+, G53SP+
| ID | ComparisonItem | Proposed Device5MP Color LCD Monitors C53S+, C53SP+;5MP Monochrome LCD Monitors G53S+,G53SP+ | Predicate Device5MP Color LCD Monitor CL-S500, 5MPMonochrome LCD Monitor MS-S500 |
|---|---|---|---|
| 1 | Intended Use | The 5MP Color LCD Monitors C53S+, C53SP+ and5MP Monochrome LCD Monitors G53S+, G53SP+are intended to be used in displaying and viewingmedical images for diagnosis by trained medicalpractitioners or certified personnel. They'reintended to be used in digital mammography PACS,digital breast tomosynthesis and modalitiesincluding FFDM. | CL-S500 and MS-S500 are intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitioners orcertified personnel. They're intended to be used indigital mammography PACS, digital breasttomosynthesis and modalities including FFDM. |
8.2 Comparison table
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| ID | ComparisonItem | Proposed Device5MP Color LCD MonitorsC53S+, C53SP+ | Predicate Device5MP Color LCD MonitorCL-S500 | Explanation of Differences |
|---|---|---|---|---|
| 2 | Display Performance/Specifications | |||
| 2.1 | Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| 2.2 | Viewing angle (H, V) | CR>10Horizontal: Typ.178Vertical: Typ.178 | CR>50Horizontal: Typ.178Vertical: Typ.178 | Different screen provided by thedifferent manufacturer |
| 2.3 | Resolution ormatrix size | 5MP(2048 X 2560) | 5MP(2048 X 2560) | - |
| 2.4 | Aspect ratio | 4:5 | 4:5 | - |
| 2.5 | Display area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | - |
| 2.7 | Response time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 920cd/m²Typ. 1,150cd/m² | Min. 920cd/m²Typ. 1,150cd/m² | - |
| 2.9 | DICOM calibratedluminance | 500cd/m² | 500cd/m² | - |
Table 2 General Comparison of C53S+, C53SP+
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510(k) Submission
| 2.10 | Contrast ratio | Min. 1600:1Typ. 2000:1 | Min. 1600:1Typ. 2000:1 | - |
|---|---|---|---|---|
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | Grayscale Tones | 10-bit (DisplayPort): 1.073billion1024 from a palette of 16,384tones8-bit(DVI): 16.77 million 256from a palette of 16,384 tones | 10-bit (DisplayPort): 1.073billion1024 from a palette of 16,369tones8-bit(DVI): 16.77 million 256from a palette of 16,369 tones | Tone between the predicatedevice and our proposeddevices are different. But theypass the exams in AAPM-TG184.3 "Luminance Response" .Therefore, they are equivalentto the predicate device. |
| 2.13 | Luminancenon-uniformitycompensation | - | Digital Uniformity CorrectionSystem | Different design scheme |
| 3 | Video Signals | |||
| 3.1 | Input video signals | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | - |
| 3.2 | Scanning Frequency(H, V) | Landscape:Horizontal: 104.852KHzVertical: 50Hz | Portrait:Horizontal: 129.1KHzVertical: 50HzLandscape:Horizontal: 103.5KHzVertical: 50Hz | - |
| 3.3 | Dot Clock | 285 MHz | 285 MHz | - |
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510(k) Submission
| 4 | Power Related Specifications | |||
|---|---|---|---|---|
| 4.1 | Power Requirements | DC 12V, 6.67A | AC 100-240V, 50/60Hz | Difference between built-inpower supply and built-outpower supply |
| 4.2 | Power Consumption /Save Mode | 80WLess than 5W | 95WLess than 1W | Compared with the predicatedevice, the proposed deviceconsumes less power in theoperating mode and morepower in the power savingmode. |
| 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 / MedivisorNXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor (only forC53SP+)Built-in Ambient Light SensorBuilt-in Backlight Sensor | Built-in Front SensorBuilt-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 234.8mm | 361.5 x 517/612 x 196.5 mm | Different housing design due tothe different panel size |
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| 5M LCD Monitors C53S+, C53SP+, G53S+, G53SP+ | ||
|---|---|---|
| -- | -- | ---------------------------------------------- |
| ID | ComparisonItem | Proposed Device5MP Monochrome LCDMonitors G53S+, G53SP+ | Predicate Device5MP Monochrome LCDMonitor 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>10Horizontal: Typ.178Vertical: Typ.178 | CR>50Horizontal: Typ.178Vertical: Typ.178 | Different screen provided by thedifferent manufacturer |
| 2.3 | Resolution ormatrix size | 5MP(2048 X 2560) | 5MP(2048 X 2560) | - |
| 2.4 | Aspect ratio | 4:5 | 4:5 | - |
| 2.5 | Display Area | Horizontal: 337.92mmVertical: 422.4mm | Horizontal: 337.92mmVertical: 422.4mm | - |
| 2.6 | Pixel pitch | Horizontal: 0.165mmVertical: 0.165mm | Horizontal: 0.165mmVertical: 0.165mm | - |
| 2.7 | Response Time (Typ.) | 25ms (On/Off) | 25ms (On/Off) | - |
| 2.8 | Maximum luminance | Min. 2,400cd/m²Typ. 3,000cd/m² | Min. 2,400cd/m²Typ. 3,000cd/m² | - |
Table 3 General Comparison of G53S+/G53SP+
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510(k) Submission
| 2.9 | DICOM calibratedluminance | 500cd/m² | 1,000cd/m² | The luminance ratio (max/min)between 250 and 650 generallyrecommended taking accountof the contrast sensitivity ofhuman eyes is available in theproposed devices. Beacondoes not see merits of theextremely high luminanceoffering contrast beyond whatthe eyes can see. |
|---|---|---|---|---|
| 2.10 | Contrast ratio | Min. 1600:1Typ. 2000:1 | Min. 1600:1Typ. 2000:1 | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 16,384 tones8-bit (DVI): 256 from a paletteof 16,384 tones | 10-bit (DisplayPort): 1,024from a palette of 16,369 tones8-bit (DVI): 256 from a paletteof 16,369 tones | Tone between the predicatedevice and our proposeddevices are different. But theypass the exams in AAPM-TG184.3 "Luminance Response".Therefore, they are equivalentto the predicate device. |
| 2.13 | Luminancenon-uniformitycompensation | - | Digital Uniformity CorrectionSystem | Different design scheme |
| 3 | Video Signals | |||
| 3.1 | Input video signals | DVI-D x1DisplayPort x1 | DVI-D x1DisplayPort x1 | - |
{14}------------------------------------------------
510(k) Submission
| 3.2 | Scanning Frequency(H, V) | Landscape:Horizontal: 104.852KHzVertical: 50Hz | Portrait:Horizontal: 129.1KHzVertical: 50HzLandscape:Horizontal: 103.5KHzVertical: 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-inpower supply and built-outpower supply |
| 4.2 | Power Consumption /Save Mode | 80WLess than 5W | 80WLess than 1W | Compared with the predicatedevice, the proposed deviceconsumes more power in thepower 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 / MedivisorNXF-CAL | Different design scheme |
| 5.2 | Sensors | Built-in Front Sensor (only forG53SP+)Built-in Ambient Light SensorBuilt-in backlight sensor | Built-in Front SensorBuilt-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 tothe different panel size |
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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.
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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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§ 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).