(61 days)
Not Found
No
The device description focuses on the technical specifications of medical display monitors (LCD panels, resolution, calibration standards, brightness control, ergonomics) and performance testing related to display characteristics. There is no mention of AI, ML, algorithms for image analysis, or any features that would suggest the use of such technologies. The "image processing" mentioned refers to standard display technology (14-bit color depth) rather than AI-driven analysis.
No
The devices are monitors intended for displaying medical images; they do not provide therapy or directly treat medical conditions.
No
The device is a medical monitor designed to display images for review and analysis by medical practitioners. It is explicitly stated that these products "do not support the display of mammography images for diagnosis." While one model (C82W+) is "specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications," the role of the device itself is to display, not to perform a diagnosis. It is a tool for diagnostic review, not a diagnostic device in and of itself.
No
The device description clearly states that the products are "TFT color LCD monitors" and describes their physical characteristics and features, indicating they are hardware devices.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states they are for "displaying digital images for review and analysis by trained medical practitioners." This is a display function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the technical specifications of the monitors for displaying medical images (Ultrasound, General Radiography, diagnostic, interventional radiology). It describes features related to image quality, calibration, and ergonomics, all related to the display of images.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
These devices are medical image displays, which are a different category of medical device than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
PGY
Device Description
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.
Mentions image processing
Yes
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 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.
- Meausure the maximum, minimum, achievable, and recommended luminance.
- Measure the temporal response using the typical data provided by the panel manufacturer.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is 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
2
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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3
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, Nanshan |
| District, Shenzhen, 518055 China | |
| Contact Name: | Fu Ailing |
| Telephone No.: | +86-0755-36868363-5150 |
| Fax No.: | +86-0755-26995755 |
| Email Address: | fuailing@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: 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.
4
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.
5
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.) |
-
|
| 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.)
10) |
| Pixel Pitch | (H) 0. 1553 × (V) 0.1553 mm |
7
| 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.) |
| 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 screen |
| provided by the | |
| different | |
| manufacturer | |
| 2.3 | Active screen |
| size | 641.28 mm x |
| 400.8 mm | 697.31 mm x |
| 392.23 mm | 596.16 mm x |
| 335.34 mm | 596.16 mm x |
| 335.34 mm | 641.28 mm x |
| 400.8 mm | Different screen |
| provided by the | |
| different | |
| manufacturer | |
| 2.4 | Resolution |
| 1,600) | 8MP (3, 840 x |
| 2,160) | 8MP (3, 840 x |
| 2,160) | 8MP (3, 840 x |
| 2,160) | 4MP (2,560 x |
| 1,600) | Different screen |
| provided by the | |
| different | |
| manufacturer | |
| 2.5 | Aspect ratio |
| 2.6 | Pixel pitch |
| 0.2505 mm | 0.182 mm x |
| 0.182 mm | 0.1553 mm x |
| 0.1553 mm | 0.1553 mm x |
| 0.1553 mm | 0.2505 mm x |
| 0.2505 mm | Different screen provided by the different manufacturer |
| 2.7 | Maximum luminance |
| 2.8 | DICOM calibrated luminance |
| 2.9 | Contrast ratio |
| 2.10 | Backlighting |
| 2.11 | Display Colors |
| 1,073,741,824 | |
| color | 1.07 Billion |
| colors | 1.07 Billion |
| colors, 10Bit | |
| (8Bit + A-FRC) | 1.07 Billion |
| colors, 10Bit | |
| (8Bit + A-FRC) | 8-bit colors: |
| 16.77 million | |
| from a palette of | |
| 68 billion colors | Tone between |
| the predicate | |
| device and our | |
| proposed devices | |
| are different. But | |
| they pass the | |
| exams in | |
| AAPM-TG18 4.3 | |
| "Luminance | |
| Response". | |
| Therefore, they | |
| are equivalent to | |
| the predicate | |
| device. | |
| 2.12 | Luminance |
| non-uniformity | |
| compensation | - |
| Uniformity | |
| Equalizer | Different design |
| scheme | |
| 3 | Video Signal Input |
| 3.1 | Input video |
| signals | DVI-D (dual link) |
| x 2, | |
| DisplayPort x 2 | |
| VGA x 1 | DVI-D (dual link) |
| x 2, | |
| DisplayPort x 2 | |
| VGA x 2 | DVI-D (dual link) |
| x 2, | |
| DisplayPort x 2 | |
| VGA x 1 | DVI-D (dual link) |
| x 2, | |
| DisplayPort x 2 | |
| VGA x 1 | DVI-D (dual link) |
| x 1, | |
| DVI-D (single | |
| link) x 1, | |
| DisplayPort x 1 | |
| scheme |
510(k) Summary
10
D Monitors C44W+, C82W+, C83W+, C85W
510(k) Submission
510(k) Summary
11
D Monitors C44W+, C82W+, C83W+, C85V
510(k) Submission
510(k) Summary
12
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510(k) Submission
| | | | Power Related Specifications | | | Power
Management | QC software | Sensors | USB
Ports/Standard | Dimensions
w/o stand (W x
H x D | Miscellaneous Features/Specifications | | | | | | |
|-----|------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------|-----------|--------------------------------------------------------------------------------------|---------------------|--------------------|-----------------------------------------|-----------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|----------------------------|
| 3.2 | Scanning
Frequency (H, V) | 31 - 140 kHz, 29
- 61 Hz
Frame 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 Monitor
Manage | Backlight
Sensor,
Integrated Front
Sensor,
Ambient Light
Sensor | 1 upstream,
2 downstream /
Rev. 2.0 | 699.3 x 459.8 x
67.7 mm | |
| | | 31 - 140 kHz, 29 - 61 Hz
Frame 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 Monitor
Manage | Backlight
Sensor | 1 upstream,
2 downstream /
Rev. 2.0 | 752.7 x 449.2 x
73.05 mm | |
| | | 31 - 140 kHz, 29 - 61 Hz
Frame 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 Monitor
Manage | Backlight
Sensor | - | 650.7 x 389.5 x
67.8 mm | |
| | | 31 - 140 kHz, 29 - 61 Hz
Frame 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 Monitor
Manage | Backlight
Sensor | - | 650.7 x 389.5 x
67.8 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 | Backlight
Sensor,
Integrated Front
Sensor,
Presence
Sensor,
Ambient Light
Sensor | 1 upstream,
2 downstream /
Rev. 2.0 | 720 x 498 x 119
mm | Different design
scheme |
| | | Different design scheme | | | | | | | | | Difference between built-in power supply and built-out power supply
Compared with the predicate device, the proposed devices consume less power normally, and more power in the power saving mode. | | | | | | Different design
scheme |
| | | | | | Different design
scheme | | | | | | | | | | | | |
| | | | | | Same for C44W+
and C82W+;
different design
scheme for
C83W+ and
C85W+ | | | | | | | | | | | | |
| | | | | | Different housing
design due to the
different panel
size | | | | | | | | | | | | |
510(k) Summary
13
510(k) Submission
D Monitors C44W+, C82W+, C83W+, C85V
510(k) Summary
14
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+.
15
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.