(21 days)
Not Found
No
The 510(k) summary describes a medical display monitor and its technical specifications and performance testing. There is no mention of AI, ML, or any image processing capabilities that would suggest the use of such technologies within the device itself. The device's function is solely to display images.
No
This device is a monitor used for displaying medical images for review, analysis, and diagnosis, not for providing therapy or treatment.
No
This device is an 8MP color LCD monitor intended for displaying and viewing digital medical images for review, analysis, and diagnosis, but it does not perform the diagnosis itself. It is a tool used in the diagnostic process by trained medical practitioners.
No
The device is explicitly described as an 8MP color LCD monitor, which is a hardware component. The description details its physical characteristics and includes bench tests related to display performance, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The C81W+ is a display monitor. Its function is to display digital images generated by other medical imaging devices (like mammography machines, ultrasound machines, etc.). It does not perform any tests on biological samples.
- Intended Use: The intended use is for "displaying and viewing digital images... for review, analysis and diagnosis". This is a display function, not a diagnostic test performed on a sample.
Therefore, the C81W+ falls under the category of a medical imaging display accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes
PGY
Device Description
The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, including standard and multi-frame digital mammography, ultrasound and general radiography.
Anatomical Site
breast
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
According to the instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions, the bench tests were performed on C81W+ 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 angle dependency of luminance response in horizontal, vertical and diaqonal directions.
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- 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.
- Measure the display reflections including specular, diffuse and haze components.
- Measure the small-spot contrast ratio.
- Measure the spatial resolution expressed as modulation transfer function (MTF).
- Measure the noise expressed as noise power spectrum (NPS).
- Measure the pixel aperture ratio.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the temporal response.
- The performance data on luminance stability
- Maximum number allowed for each type of pixel defects/faults
The test results showed that C81W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX850 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C81W+.
Key Metrics
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Beacon Display Technology Co., Ltd. % Miss Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA
October 6, 2016
Re: K162527 Trade/Device Name: 8MP Color LCD Monitor (C81W+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 1, 2016 Received: September 9, 2016
Dear Miss Ailing:
This letter corrects our substantially equivalent letter of September 30, 2016.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jeff Rodriquez
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
8MP Color LCD Monitor (C81W+)
Indications for Use (Describe)
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
008_510 (k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 6, 2016
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|---|---|
| Address: | 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road, Nanshan |
| District, Shenzhen, 518055 China | |
| Contact Name: | Fu Ailing |
| Telephone No.: | +86-0755-33985118-5150 |
| Fax No.: | +86-0755-26995755 |
| Email Address: | fuailing@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name/Model: | 8MP Color LCD Monitor (C81W+) |
|---|---|
| Common Name: | 8MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product code: | PGY |
| Classification Panel: | Radiology |
| Device Class: | II |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows:
EIZO Corporation, 8MP Color LCD Monitor, RadiForce RX850, RX850-AR has been cleared by FDA through 510(k) No. K152713 (Decision Date - November 20, 2015).
5
5. Description of the Device [21 CFR 807.92(a) (4)]
The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6. Intended Use [21 CFR 807.92(a)(5)]
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| Panel | 31", TFT, color, LCD screen, anti-glare, hard coating |
|---|---|
| Brightness (Max.) | 850 cd/m² |
| CR (Typ.) | 1450:1 |
| Viewing angle | R/L 178°, U/D 178° Typ. (CR > 10) |
| Pixel Pitch | (H) 0.1704 × (V) 0.1704 mm |
| Native resolution | 4,096 x 2,160 |
| Display area | 697.9mm(H)x368.0mm (V) |
| Compatible video | |
| signals | 4096 x 2160@60Hz; DP/DVI |
| Horizontal resolution | 4096 |
| Aspect ratio | 17:9 |
| Screen size | 31.1" real diagonal |
| Power | DC 24V/9A |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
6
| Power consumption | Max. 180 W |
|---|---|
| Input signals | DVI-D, Display Port |
| Digital input | TMDS (dual link) * 2 |
| Plug and play | VESA DDC 2B |
| Dimension | 755 mm (W) x 600.6 mm (H) x 251.4mm (D) (with stand) 755 mm (W) x 433.8 mm (H) x 99.1 mm (D) (without stand) |
| Weight | 13 kg (without Stand) 17.5 kg (with Stand) |
| Operating temperature and humidity | Temperature: 0°C ~ 40°C Humidity: 20% ~80% |
| Storage temperature and humidity | Temperature: -20°C ~ 60°C Humidity:10% ~90% |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
Table 1 Intended Use Comparison
| ID | Comparison Item | Proposed Device
8MP Color LCD Monitor
(C81W+) | Predicate Device
8MP Color LCD Monitor
(RX850, RX850-AR) | |
|------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 1 | Intended Use | The 8MP Color LCD Monitor
(C81W+) is intended to be
used in displaying and viewing
digital images, including
standard and multi-frame
digital mammography, for
review, analysis and diagnosis
by trained medical
practitioners. It is specially
designed for breast
tomosynthesis applications. | "8MP Color LCD Monitor
(RX850, RX850-AR)" is intended
to be used in displaying and
viewing digital images, including
standard and multi-frame digital
mammography, for review,
analysis and diagnosis by trained
medical practitioners. It is
specially designed for breast
tomosynthesis application. | |
| ID | Comparison Item | Proposed Device
8MP Color LCD
Monitor (C81W+) | Predicate Device
8MP Color LCD
Monitor
(RX850, RX850-AR) | Explanation of
Difference |
| 2 | Display Performance/Specifications | | | |
| 2.1 | Screen
Technology | TFT Color LCD Panel
(IPS) | TFT Color LCD Panel
(IPS) | - |
| 2.2 | Viewing angle
(H, V) | H: 178°, V: 178° | H: 178°, V: 178° | - |
| 2.3 | Resolution | 8MP (4,096 x 2,160) | 8MP (4,096 x 2,160)
(4MP: 2,048 x 2,160
x2) | - |
| 2.4 | Aspect ratio | 17:9 (8.5 : 9 x 2) | 17:9 (8.5 : 9 x 2) | - |
| 2.5 | Active screen
size | 697.9 mm x 368.0 mm | 697.9 mm x 368.0 mm | - |
| 2.6 | Pixel pitch | 0.1704 mm x 0.1704
mm | 0.1704 mm x 0.1704
mm | - |
| 2.7 | Maximum
luminance | 850 cd/m² | 850 cd/m² | - |
| 2.8 | DICOM
calibrated
luminance | 500 cd/m² | 500 cd/m² | - |
| 2.9 | Contrast ratio | 1450:1 | 1450:1 | - |
| 2.10 | Response
Time (typ.) | 20 ms (On/Off) | 20 ms (On/Off) | - |
| 2.11 | Backlighting | LED | LED | - |
| 2.12 | Grayscale
Tones | From a palette of 68
billion colors:
- 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | From a palette of 68
billion colors: - 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | - |
| 2.13 | Luminance
non-uniformity | Digital Uniformity
Equalizer | Digital Uniformity
Equalizer | - |
| 3 | Video Signal Input | | | |
| 3.1 | Input video signals | DVI-D (dual link) x 2, DisplayPort x 2 | DVI-D (dual link) x 2, DisplayPort x 2 (two inputs are required) | – |
| 3.2 | Scanning Frequency (H, V) | 31 - 140 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz) Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 140 kHz / 59 - 61 Hz (VGA Text: 69 - 71 Hz) Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz | – |
| 4 | Power Related Specifications | | | |
| 4.1 | Power Requirements | DC24V/9.0A | AC 100 - 120V, 200 - 240 V: 50 / 60 Hz | The difference between Built-in power supply and Built-out power supply. |
| 4.2 | Power Consumption / Save Mode | 180 W / Less than 5 W | 227 W / Less than 6 W | Different design scheme. |
| 4.3 | Power Management | DVI DMPM, DisplayPort 1.2 | DVI DMPM, DisplayPort 1.1a | Different design scheme. |
| 5 | Miscellaneous Features/Specifications | | | |
| 5.1 | QC software | Beacon Monitor Manage | RadiCS | Different design scheme. |
| 5.2 | Sensor | Backlight Sensor, Integrated Front Sensor, Ambient Light Sensor | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor | – |
| 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) | 755 x 433.8 x 99.1 mm | 747 x 430 x 130 mm | Different housing design due to the different panel size. |
8.2 Comparison table
Table 2 General Comparison
7
8
9
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C81W+.
8.3 Performance Testing
According to the instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions, the bench tests were performed on C81W+ 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 angle dependency of luminance response in horizontal, vertical and diaqonal directions.
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 quideline.
- 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.
- Measure the display reflections including specular, diffuse and haze components.
- Measure the small-spot contrast ratio.
- Measure the spatial resolution expressed as modulation transfer function (MTF).
- Measure the noise expressed as noise power spectrum (NPS).
- Measure the pixel aperture ratio.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the temporal response.
- The performance data on luminance stability
- Maximum number allowed for each type of pixel defects/faults
The test results showed that C81W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX850 except some items, each of which was determined that it would not affect observer's performance.
10
No animal or clinical testing is needed for C81W+.
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 C81W+ is totally same as that of the predicate device.
- The technological characteristics differences between C81W+ and RadiForce RX850 do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of C81W+ are equivalent to those of the predicate device.