(89 days)
Not Found
No
The description focuses on the display technology and calibration standards, with no mention of AI or ML algorithms for image analysis or processing beyond standard display functions.
No
The device is a monitor used for displaying digital images for review and analysis by medical practitioners. It does not provide any therapy or treatment.
No
This device is a monitor used for displaying digital images for review and analysis, not for making a diagnosis itself. The text explicitly states, "It does not support the display of mammography images for diagnosis." and its intended use is for "displaying digital images for review and analysis."
No
The device description clearly states it is a 30-inch TFT color LCD monitor, which is a hardware component. The performance studies also focus on the physical characteristics of the display.
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 C61W+ monitor is a display device used to show digital images for review and analysis. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display digital images for review and analysis by medical practitioners, specifically for general radiography. It explicitly states it does not support the display of mammography images for diagnosis.
- Device Description: The description focuses on the technical specifications of the monitor for displaying images, not on analyzing biological samples.
Therefore, the C61W+ monitor falls under the category of a medical device used for displaying medical images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes
PGY, LLZ
Device Description
C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography.
With built-in multi-display modes, the monitor 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, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
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
The bench tests were performed on C61W+ as below.
- Verify the conformance to DICOM GSDF in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 quideline).
- Measure the 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 guideline.
- Measure the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance in accordance with Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k) Submissions.
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 quideline.
- Maximum number allowed for each type of pixel defects/faults.
The test results showed that C61W+ is with display characteristics equivalent to those of the predicate device, RadiForce RX650 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C61W+.
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).
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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 Zhivuan. No.1001 Xuevuan Road Shenzhen, 518055 Cn
December 13, 2018
Re: K182291
Trade/Device Name: 6MP Color LCD Monitor (C61W+) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PGY Dated: September 25, 2018 Received: October 1, 2018
Dear Fu Ailing:
This letter corrects our substantially equivalent letter of November 20, 2018.
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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bargas
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
6MP Color LCD Monitor (C61W+)
Indications for Use (Describe)
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary K182291
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
July 26, 2018
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 +86-0755-33985118-5150 Telephone No.:
+86-0755-26995755 Fax No.:
Email Address: fuailing@beacon-display.cn
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: 6MP Color LCD Monitor (C61W+) Common Name: 6 6MP Color LCD Monitor Classification Name: System, Image Processing, Radiological Requlation Number: 21 CFR 892.2050 Product code: LLZ 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, 6MP Color LCD Monitor, RadiForce RX650 has been cleared by FDA through 510(k) No. K134002 (Decision Date - January 31, 2014).
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5. Description of the Device [21 CFR 807.92(a) (4)]
C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography.
With built-in multi-display modes, the monitor 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, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
6. Intended Use [21 CFR 807.92(a)(5)]
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
| Monitor characteristics: | |
|---|---|
| Screen technology | 30", TFT, color, LCD screen, anti-glare, hard coating |
| Active area (H x V) | 654.4 x 408.6 mm |
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Screen technology | 30", TFT, color, LCD screen, anti-glare, hard coating | |
|---|---|---|
| Active area (H x V) | 654.4 x 408.6 mm | |
| Pixel pitch | 0.197 mm (H) x 0.197mm (V) | |
| Resolution | 3,280 x 2,048 Pixels | |
| Contrast ratio | 950:1 (Typ.), 750:1 (Min.) | |
| Viewing angle (CR > 10) | Horizontal: 170° (Typ.) | |
| Vertical: 170° (Typ.) | ||
| Brightness | 800 cd/m² (Typ.) | |
| Refresh rate | 50 Hz | |
| Backlight | LED | |
| Lifetime of backlight | 50,000 hours | |
| Response time (Tr + Tf) | 30 ms (Typ.) | |
| Color support | 1.07 billion | |
| Power supply: | ||
| Power connection | Adapter (FSP, FSP220-KAAM1, Input: 100-240 V, 47-63 Hz; 2.5-1.2 A; Output: 24 V; 9.17 A, Max. 220 W). | |
| The approved adapter is considered as part of LCD Monitor. | ||
| Line voltage | 24 V | |
| Current consumption | 9.0 A | |
| Power consumption | 160 W (Max.) | |
| Standby |