(61 days)
These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.
C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output 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 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.
For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.
The provided document describes the 510(k) premarket notification for Shenzhen Beacon Display Technology Co., Ltd.'s 4MP/8MP Color LCD Monitors (C44W+/C82W+, C83W+, C85W+). These monitors are intended for displaying digital images for review and analysis by trained medical practitioners, excluding mammography images for diagnosis.
The study presented is a bench test comparison to a legally marketed predicate device, the Eizo Nanao Corporation RadiForce RX440 (K130070). The purpose of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to establish the device's absolute performance against a set of clinical acceptance criteria for diagnosis.
Here is an analysis based on your requested information, referencing the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study targeting specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating equivalence to a predicate device based on technical display characteristics and conformance to relevant industry guidelines (AAPM Task Group 18 (TG18 guideline)).
The "reported device performance" are the results of the bench tests on the proposed devices (C44W+, C82W+, C83W+, C85W+) showing their technical specifications and how they align with or differ from the predicate device. The document generally concludes that the devices are equivalent to the predicate.
Here's a summary of key performance tests conducted, which serve as the basis for their claim of equivalence:
| Acceptance Criteria (based on AAPM TG18 guidelines and general display characteristics) | Reported Device Performance (for C44W+, C82W+, C83W+, C85W+) |
|---|---|
| Measure the spatial resolution expressed as Modulation Transfer Function (MTF) | Not explicitly detailed, but implied to be sufficient. |
| Verify conformance to DICOM GSDF in accordance with TG18 guideline | Explicitly stated that proposed devices are designed to meet DICOM 3.14 calibration standards and pass the exams in AAPM-TG18 4.3 "Luminance Response". The tone between the predicate device and proposed devices are different, but deemed equivalent in this aspect. |
| Measure the luminance non-uniformity characteristics of the display screen (TG18) | Bench tests performed; implied to meet requirements. |
| Measure the chromaticity non-uniformity characteristics of the display screen (TG18) | Bench tests performed; implied to meet requirements. |
| Visually check the presence or absence of miscellaneous artifacts (TG18) | Bench tests performed; implied to meet requirements. |
| Measure maximum, minimum, achievable, and recommended luminance | Max luminance: C44W+ (700 cd/m²), C82W+ (1000 cd/m²), C83W+/C85W+ (800 cd/m²). DICOM calibrated luminance: 500 cd/m² (all proposed). Predicate: Max luminance (750 cd/m²), DICOM calibrated luminance (400 cd/m²). Differences noted, but not considered to affect safety/effectiveness. |
| Measure the temporal response (using panel manufacturer data) | Response time: C44W+ (6 ms), C82W+ (14 ms), C83W+/C85W+ (16 ms). |
| Maximum number allowed for each type of pixel defects/faults | Bench tests performed; implied to meet requirements. |
| Measure the chromaticity at the center of the display screen (5%, 50%, 95% max luminance) (FDA Guidance for FFDMM Systems) | Bench tests performed; implied to meet requirements. |
| Measure the color tracking (primary colors and color gamut) | Bench tests performed; implied to meet requirements. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2. Sample size used for the test set and the data provenance
The study involves bench testing of the devices themselves (C44W+, C82W+, C83W+, C85W+). It's not a study involving patient data or human interpretation. Therefore, "sample size" and "data provenance" in the context of clinical images or patient data are not applicable. The "test set" consists of the physical display units being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a technical performance study of a device (monitor), not a diagnostic accuracy study using medical images interpreted by experts. Therefore, "ground truth" in the context of expert consensus on medical images is not applicable. The ground truth is adherence to technical specifications and industry standards like AAPM TG18. The "experts" involved would be the technical personnel performing the bench testing and evaluating the results against established standards, but their specific number and qualifications are not mentioned in this document.
4. Adjudication method for the test set
"Adjudication method" is not applicable as this is a technical performance study of display monitors, not an evaluation of diagnostic interpretations where consensus among readers would be required.
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, an MRMC comparative effectiveness study was not done. This submission is for medical display monitors, not an AI-powered diagnostic tool. The document focuses on the technical characteristics and equivalence of the monitors to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question refers to AI algorithm performance. Since the device is a medical display monitor and not an AI algorithm, a standalone performance study in that context was not done. The study performed was a technical assessment of the monitor's display capabilities.
7. The type of ground truth used
The "ground truth" for this technical assessment is adherence to technical specifications, industry standards (e.g., DICOM 3.14, AAPM TG18 guidelines), and comparison with the predicate device's established performance. It's not based on pathology, expert consensus on medical images, or patient outcomes data.
8. The sample size for the training set
This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, a "training set" is not applicable.
9. How the ground truth for the training set was established
This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, the concept of establishing ground truth for a training set is not applicable.
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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. % Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA
Re: K202374
Trade/Device Name: 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: August 15, 2020 Received: August 19, 2020
October 19, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
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 mediation-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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Indications for Use
510(k) Number (if known)
K202374
Device Name
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
Indications for Use (Describe)
These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They 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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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 1, 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: 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ Common Name: LCD Monitors C44W+, C82W+, C83W+, C85W+ 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: Eizo Nanao Corporation, RadiForce RX440 has been cleared by FDA through 510(k) No.
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K130070 (Decision Date - February 08, 2013).
5. Description of the Device [21 CFR 807.92(a) (4)]
C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.
C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output 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 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.
For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.
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6. Intended Use [21 CFR 807.92(a)(5)]
These products are intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel | 30", TFT, color, LCD screen, AG type, 3H hard coating |
|---|---|
| Brightness (Typ.) | 700 cd/m² |
| CR (Typ.) | 1000:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 2505 × (V) 0.2505 mm |
| Native resolution | 2,560 x 1,600 |
| Display area | 641.28 mm (H) x 400.8 mm (V) |
| Aspect ratio | 16:10 |
| Screen size | 30" real diagonal |
| Power | DC 24 V/9 A |
| Power consumption | 80 W (max.)< 5 W (standby) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Response time (Gray to gray) | 6 ms (typ.) |
| Color support | 1.073G |
| Input signals | DVI-D, Display Port, VGA |
| Dimension (W x H x D) | 699.3 x 513~633 x 251.4 mm (without packing)864 x 600 x 334 mm (with packing) |
| Weight | 13 ± 0.5 kg (wet)15 ± 0.5 kg (gross) |
| Operating temperature and humidity | Temperature: 0°C ~ 40°CHumidity: 20% ~ 80% |
| Storage temperature and humidity | Temperature: -20°C ~ 60°CHumidity:10% ~ 90% |
C44W+ Color LCD monitor
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| Panel | 31.5", TFT, color, LCD screen, AG type |
|---|---|
| Brightness (Typ.) | 1000 cd/m² |
| CR (Typ.) | 1300:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 182 × (V) 0.182 mm |
| Native resolution | 3,840 x 2,160 |
| Display area | 697.31 mm (H) x 392.23 mm (V) |
| Aspect ratio | 16:9 |
| Screen size | 31.5" real diagonal |
| Power | DC 24 V/9.0 A |
| Power consumption | 160 W (max.)< 5 W (standby) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Response time (Grayto Gray) | 14 ms (typ.) |
| Color support | 1.07B |
| Input signals | DVI-D, Display Port, VGA |
| Dimension (W x H x D) | 753 x 503~583 x 251 mm (without packing)850 x 580 x 320 mm (with packing) |
| Weight | 18.5 kg ± 0.5 kg (wet)23.5 ± 0.5 kg (gross) |
| Operatingtemperature andhumidity | Temperature: 0°C ~ 40°CHumidity: 20% ~ 80% |
C82W+ Color LCD monitor
C83W+/C85W+ Color LCD monitor
| Panel | 27", TFT, color, LCD screen, AG type, 3H hard coating |
|---|---|
| Brightness (Typ.) | 800 cd/m² |
| CR (Typ.) | 1000:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0. 1553 × (V) 0.1553 mm |
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| Native resolution | 3,840 x 2,160 |
|---|---|
| Display area | 596.16 mm (H) x 335.34 mm (V) |
| Aspect ratio | 16:9 |
| Screen size | 27" real diagonal |
| Power | DC 24 V/5.0 A |
| Power consumption | 100 W (max.)< 5 W (standby) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Response time ( TR + TF ) | 16 ms (typ.) |
| Color support | 1.07B |
| Input signals | DVI-D, Display Port, VGA |
| Dimension (W x H x D) | 651 x 463~583 x 251.4 mm (without packing)764 x 556 x 344 mm (with packing) |
| Weight | 10 ± 0.5 kg (wet)13 ± 0.5 kg (gross) |
| Operatingtemperature andhumidity | Temperature: 0°C ~ 40°CHumidity: 20% ~ 80% |
| Storage temperatureand 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 uses:
| ID | ComparisonItem | Proposed DevicesC44W+, C82W+, C83W+,C85W+ | Predicate DeviceRadiForce RX440 |
|---|---|---|---|
| 1 | IntendedUse | These products are intended tobe used in displaying andviewing digital images for reviewand analysis by trained medicalpractitioners. They do notsupport the display ofmammography images fordiagnosis. | The product is intended to beused in displaying and viewingdigital images for review andanalysis by trained medicalpractitioners. They do notsupport the display ofmammography images fordiagnosis. |
Table 1 Intended Use Comparison of C44W+, C82W+, C83W+, C85W+
8.2 Comparison table
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D Monitors C44W+, C82W+, C83W+, C83W+, C85W
510(k) Submission
| Table 2 | General Comparison of |
|---|---|
| C44W+, | C82W+, C83W+, C85W+ |
| ID | ComparisonItem | Proposed Devices | PredicateDevice | Explanation ofDifferences | ||||
|---|---|---|---|---|---|---|---|---|
| C44W+ | C82W+ | C83W+ | C85W+ | RadiForce RX440 | ||||
| 2 | Display Performance/Specifications | |||||||
| 2.1 | Screentechnology | TFT Color LCDPanel (IPS) | TFT Color LCDPanel (IPS) | TFT Color LCDPanel (IPS) | TFT Color LCDPanel (IPS) | TFT Color LCDPanel (IPS) | ||
| 2.2 | Viewing angle(H, V) | H: 178°, V:178°@CR>10 | H: 178°, V:178°@CR>10 | H: 178°, V:178°@CR>10 | H: 178°, V:178°@CR>10 | H: 176°, V:176°@CR=10 | Different screenprovided by thedifferentmanufacturer | |
| 2.3 | Active screensize | 641.28 mm x400.8 mm | 697.31 mm x392.23 mm | 596.16 mm x335.34 mm | 596.16 mm x335.34 mm | 641.28 mm x400.8 mm | Different screenprovided by thedifferentmanufacturer | |
| 2.4 | Resolution | 4MP (2,560 x1,600) | 8MP (3, 840 x2,160) | 8MP (3, 840 x2,160) | 8MP (3, 840 x2,160) | 4MP (2,560 x1,600) | Different screenprovided by thedifferentmanufacturer | |
| 2.5 | Aspect ratio | 16:10 | 16:9 | 16:9 | 16:9 | 16:10 | Different screen provided by the different manufacturer | |
| 2.6 | Pixel pitch | 0.2505 mm x0.2505 mm | 0.182 mm x0.182 mm | 0.1553 mm x0.1553 mm | 0.1553 mm x0.1553 mm | 0.2505 mm x0.2505 mm | Different screen provided by the different manufacturer | |
| 2.7 | Maximum luminance | 700 cd/m² | 1000 cd/m² | 800 cd/m² | 800 cd/m² | 750 cd/m² | Different screen provided by the different manufacturer | |
| 2.8 | DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | 500 cd/m² | 500 cd/m² | 400 cd/m² | Different screen provided by the different manufacturer | |
| 2.9 | Contrast ratio | 1000:1 | 1300:1 | 1000:1 | 1000:1 | 1100:1 | Different screen provided by the different manufacturer | |
| 2.10 | Backlighting | LED | LED | LED | LED | LED | - | |
| 2.11 | Display Colors | 10-bit,1,073,741,824color | 1.07 Billioncolors | 1.07 Billioncolors, 10Bit(8Bit + A-FRC) | 1.07 Billioncolors, 10Bit(8Bit + A-FRC) | 8-bit colors:16.77 millionfrom a palette of68 billion colors | Tone betweenthe predicatedevice and ourproposed devicesare different. Butthey pass theexams inAAPM-TG18 4.3"LuminanceResponse".Therefore, theyare equivalent tothe predicatedevice. | |
| 2.12 | Luminancenon-uniformitycompensation | - | - | - | - | - | DigitalUniformityEqualizer | Different designscheme |
| 3 | Video Signal Input | |||||||
| 3.1 | Input videosignals | DVI-D (dual link)x 2,DisplayPort x 2VGA x 1 | DVI-D (dual link)x 2,DisplayPort x 2VGA x 2 | DVI-D (dual link)x 2,DisplayPort x 2VGA x 1 | DVI-D (dual link)x 2,DisplayPort x 2VGA x 1 | DVI-D (dual link)x 1,DVI-D (singlelink) x 1,DisplayPort x 1 | Different designscheme |
510(k) Summary
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D Monitors C44W+, C82W+, C83W+, C85W
510(k) Submission
510(k) Summary
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D Monitors C44W+, C82W+, C83W+, C85V
510(k) Submission
510(k) Summary
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510(k) Submission
| Power Related Specifications | PowerManagement | QC software | Sensors | USBPorts/Standard | Dimensionsw/o stand (W xH x D | Miscellaneous Features/Specifications | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3.2 | ScanningFrequency (H, V) | 31 - 140 kHz, 29- 61 HzFrame synchronous mode: 59 - 61 Hz, 29.5 - 30.5 Hz | 3.3 | Dot Clock | 268 MHz | 4.1 | Power Requirements | DC 24 V / 9 A | 4.2 | Power Consumption/Save Mode | 80 W / Less than 5 W | DVI DMPM,DisplayPort 1.2 | Beacon MonitorManage | BacklightSensor,Integrated FrontSensor,Ambient LightSensor | 1 upstream,2 downstream /Rev. 2.0 | 699.3 x 459.8 x67.7 mm | |
| 31 - 140 kHz, 29- 61 HzFrame synchronous mode: 59 - 61 Hz, 29.5 - 30.5 Hz | 533 MHz | DC 24 V / 9 A | 160 W / Less than 5 W | DVI DMPM,DisplayPort 1.2 | Beacon MonitorManage | BacklightSensor | 1 upstream,2 downstream /Rev. 2.0 | 752.7 x 449.2 x73.05 mm | |||||||||
| 31 - 140 kHz, 29- 61 HzFrame synchronous mode: 59 - 61 Hz, 29.5 - 30.5 Hz | 533 MHz | DC 24 V / 5 A | 100 W / Less than 5 W | DVI DMPM,DisplayPort 1.2 | Beacon MonitorManage | BacklightSensor | - | 650.7 x 389.5 x67.8 mm | |||||||||
| 31 - 140 kHz, 29- 61 HzFrame synchronous mode: 59 - 61 Hz, 29.5 - 30.5 Hz | 533 MHz | DC 24 V / 5 A | 100 W / Less than 5 W | DVI DMPM,DisplayPort 1.2 | Beacon MonitorManage | BacklightSensor | - | 650.7 x 389.5 x67.8 mm | |||||||||
| 31 - 159 kHz, 29- 61 Hz (VGA Text: 69 - 71 Hz)Frame synchronous mode: 59 - 61 Hz, 29.5 - 30.5 Hz | 280 MHz | AC 100 - 120 V, 200 - 240 V; 50 / 60 Hz | 167 W / Less than 0.7 W | DVI DMPM,DisplayPort 1.1a | RadiCS | BacklightSensor,Integrated FrontSensor,PresenceSensor,Ambient LightSensor | 1 upstream,2 downstream /Rev. 2.0 | 720 x 498 x 119mm | Different designscheme | ||||||||
| Different design scheme | Difference between built-in power supply and built-out power supplyCompared with the predicate device, the proposed devices consume less power normally, and more power in the power saving mode. | Different designscheme | |||||||||||||||
| Different designscheme | |||||||||||||||||
| Same for C44W+and C82W+;different designscheme forC83W+ andC85W+ | |||||||||||||||||
| Different housingdesign due to thedifferent panelsize |
510(k) Summary
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510(k) Submission
D Monitors C44W+, C82W+, C83W+, C85V
510(k) Summary
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It is clear that the technological characteristic differences discussed above do not affect the safety and the effectiveness of the C44W+, C82W+, C83W+, C85W+.
8.3 Performance Testing
The bench tests were performed on C44W+, C82W+, C83W+, C85W+ as below.
- Measure the spatial resolution expressed as modulation transfer function (MTF).
- 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 quideline.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 quideline.
- O Meausure the maximum, minimum, achievable, and recommended luminance.
- Measure the temporal response using the typical data provided by the panel manufacturer.
- 0 Maximum number allowed for each type of pixel defects/faults
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions.
- Measure the color tracking (primary colors and color gamut).
The test results showed that C44W+, C82W+, C83W+ are with display characteristics equivalent to those of the predicate device, RadiForce RX440 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C44W+, C82W+, C83W+, C85W+.
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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 C44W+, C82W+, C83W+, C85W+ is totally same as that of the predicate device.
- The technological characteristic differences between C44W+, C82W+, C83W+, C85W+ and the predicate device do not affect the safety and effectiveness, so no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C44W+, C82W+, C83W+, C85W+ are equivalent to those of the predicate device.
§ 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).