(121 days)
Not Found
No
The device description and performance studies focus on the display characteristics and conformance to standards like DICOM and TG18, with no mention of AI or ML capabilities for image analysis or processing.
No
This device is a medical monitor used for displaying radiological images for diagnosis, not for providing therapy.
No
This device is a monitor used for displaying radiological images for review, analysis, and diagnosis, but it does not perform the diagnostic function itself. It is a display tool, not a diagnostic device.
No
The device description clearly states it is a "3MP Color LCD monitors" and "3MP Monochrome LCD monitors," which are hardware components. The performance studies also describe physical measurements of the display characteristics.
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 such as blood, urine, or tissue taken from the human body to detect diseases or other conditions.
- Device Function: The described devices are medical monitors used for displaying radiological images (X-ray, MRI) for diagnosis. They are output devices for medical imaging systems, not devices that perform tests on biological samples.
- Intended Use: The intended use clearly states displaying radiological images for review, analysis, and diagnosis. This aligns with the function of a medical display, not an IVD.
- Device Description: The description focuses on the technical specifications of the monitors for displaying images, such as resolution, calibration to DICOM standards, and brightness stabilization. This is consistent with a display device.
- Performance Studies: The performance studies described are focused on the display characteristics and image quality of the monitors (luminance, uniformity, resolution, etc.), not on the accuracy or performance of a diagnostic test on a biological sample.
Therefore, these monitors are classified as medical devices, specifically medical displays, but they do not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.
The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI, etc.
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 the proposed devices C32S+, C32SP+, G32S+, G32SP+ as below.
-
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline).
-
- Measure the luminance non-uniformity characteristics of the display screen in accordance with TG18 quideline.
-
- Measure the luminance stability with the temperature 0 ℃ , 25 ℃ and 40 ℃ on Luminance response by AAPM-TG18.
-
- Measure the luminance at the angles of 30° and 45° 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 quideline.
-
- Measure the spatial noise by noise power spectrum.
-
- Measure the spatial resolution expressed as modulation transfer function (MTF)
-
- Maximum number allowed for each type of pixel defects/faults
-
- Meausure the maximum, minimum, achievable, and recommended luminance.
-
- Measure the color tracking (primary colors and color gamut).
The test results showed that C32S+, C32SP+, G32S+, G32SP+ are with display characteristics equivalent to those of the predicate devices, RadiForce RX360, RX360-AR and 3MP Monochrome LCD Monitor, RadiForce GX340 except some items, each of which was determined that it would not affect observer's performance. No animal or clinical testing is needed for C32S+, C32SP+, G32S+, G32SP+.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Shenzhen Beacon Display Technology Co., Ltd. % Fu Ailing Document Engineer 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, Guangdong 518055 CHINA
Re: K201211
Trade/Device Name: 3MP Color LCD Monitors C32S+, C32SP+, 3MP Monochrome LCD Monitors G32S+, G32SP+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 28, 2020 Received: August 6, 2020
September 3, 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
1
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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Indications for Use
510(k) Number (if known)
Device Name
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
Indications for Use (Describe)
The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
| 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)]
April 15, 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: 3MP Color LCD Monitors C32S+, C32SP+;
3MP Monochrome LCD Monitors G32S+, G32SP+
- Common Name: 3MP LCD Monitors C32S+, C32SP+, G32S+, G32SP+
Classification Name: Picture archiving and communications system
Requlation Number: 21 CFR 892.2050
Product code: PGY
Classification Panel: Radiology
Device Class: Il
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate within this submission is as follows:
4
EIZO Corporation, RadiForce RX360, RX360-AR has been cleared by FDA through 510(k) No. K182591 (Decision Date - October 18, 2018).
EIZO NANAO Corporation, 3MP Monochrome LCD Monitor, RadiForce GX340 has been cleared by FDA through 510(k) No. K113784 (Decision Date - May 4, 2012).
5. Description of the Device [21 CFR 807.92(a) (4)]
3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.
The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.
6. Intended Use [21 CFR 807.92(a)(5)]
The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
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7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Monitor characteristics: | ||
|---|---|---|
| Screen technology | 21.3", TFT, color, LCD screen, anti-glare, hard coating | |
| Active area(H x V) | 324.86 x 433.15 mm | |
| Pixel pitch | 0.2115 mm (H) x 0.2115 mm (V) | |
| Resolution | 1536 x 2048 | |
| Contrast ratio | 1500:1 (typical), 1200:1 (minimal) | |
| Viewing angle (CR > 10 ) | Horizontal: 178° (typical) | |
| Vertical: 178° (typical) | ||
| Screen brightness | 1000 cd/m² (typical) | |
| Refresh rate | 60 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50000 hours | |
| Response time (Ton + Toff) | 25 ms (typical) | |
| Power supply: | ||
| Line voltage | 12 V | |
| Current consumption | 6.67 A | |
| Power consumption | 80 W (maximum) | |
| Standby | 10 ) | Horizontal: 170° (typical) |
| Vertical: 170° (typical) | ||
| Screen brightness | 2000 cd/m² (typical) | |
| Refresh rate | 60 Hz | |
| Backlighting | LEDs | |
| Lifetime of backlight | 50000 hours | |
| Response time ( Ton + Toff ) | 28 ms (typical) |
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| Power supply: | |
|---|---|
| Line voltage | 12 V |
| Current consumption | 6.67 A |
| Power consumption | 50 W (maximum) |
| Standby |