(129 days)
Not Found
No
The description focuses on the hardware specifications of a display monitor and its performance against established display standards (DICOM GSDF, AAPM TG18). There is no mention of AI or ML algorithms being used for image analysis, processing beyond basic display functions, or any other aspect of the device's operation.
No
The device is a display monitor used to review, analyze, and diagnose radiological images. It does not exert a therapeutic effect on a patient.
Yes
The "Intended Use / Indications for Use" section states that the product is "indicated for use in displaying radiological images... for review, analysis, and diagnosis by trained medical practitioners." This explicitly mentions "diagnosis" as an intended use, which classifies it as a diagnostic device.
No
The device description explicitly states that the devices are "12MP color LCD monitors" and details hardware components like the LED backlight panel, sensors, and screen characteristics. The performance studies also focus on the physical display characteristics of the monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "displaying radiological images... for review, analysis, and diagnosis by trained medical practitioners." This describes a device used for viewing and interpreting medical images, which is a function of medical imaging devices, not IVDs.
- Device Description: The description focuses on the technical specifications of a medical monitor designed for displaying high-resolution radiological images. This aligns with the characteristics of a medical imaging display device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro testing. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
- Performance Studies: The performance studies described are focused on the display characteristics and image quality of the monitor, which are relevant to medical imaging displays, not IVDs. The studies reference guidelines for display performance in medical imaging (AAPM TG18).
- Predicate Device: The predicate device is also a medical monitor (RadiForce RX1270), further supporting that this device falls under the category of medical imaging displays.
In summary, the device's intended use, description, and performance studies all point to it being a medical imaging display device used for viewing and interpreting radiological images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare 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
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Input Imaging Modality
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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)
According to the instructions in" Guidance for Industry and Food and Drug Administration Staff Display Devices for Diagnostic Radiology", the bench tests were performed on C1216W and C12*** 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 guideline.
- Measure the luminance stability and chromaticity response with the temperature 0°C, 25°C and 40°C on Luminance response by AAPM-TG18.
- Measure the chromaticity non-uniformity characteristics of the display screen in accordance with TG18 guideline.
- Measure the luminance at the angles of 30º and 45º 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.
- Measurement of Luminance
- Visually check the presence or absence of miscellaneous artifacts on the display screen in accordance with TG18 guideline.
- Measure the spatial noise by noise power spectrum.
- Measure the reflection coefficient with specular reflection and diffuse reflection by TG18.
- Measure the veiling glare of small-spot contrast performing veiling glare test by TG-18.
- Measure the spatial resolution expressed as modulation transfer function (MTF)
- Maximum number allowed for each type of pixel defects/faults
- Measurement of Color tracking and Gray tracking
- Measure pixel fill factor like pixel structure and aperture ratio etc.
The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device, RadiForce RX1270 except some items, each of which was determined that it would not affect observer's performance.
No animal or clinical testing is needed for C1216W and C12**.
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).
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Image /page/0/Picture/0 description: The image shows the date August 18, 2023. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is centered and takes up most of the image.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Beacon Display Technology Co., Ltd. % Li Yafei Official Correspondent 15F, Building 6, Hengda Shishang Huigu (East), Fulong Road, Dalang Subdistrict. Longhua Shenzhen, Guangdong 518109 CHINA
Re: K231026
Trade/Device Name: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: July 19, 2023 Received: July 19, 2023
Dear Li Yafei:
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.
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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 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.
Zhkke
, for
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231026
Device Name
12MP Color LCD Monitor (C1216W, C12** (1*) = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models))
Indications for Use (Describe)
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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)]
August 17, 2023
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|---|---|
| Address: | 15F, Building 6, Hengda Shishang Huigu(East), Fulong Road, Dalang |
| Subdistrict, Longhua, Shenzhen, 518109 China | |
| Contact Name: | Li Yafei |
| Telephone No.: | +86-024-88087610 |
| Fax No.: | +86-024-88087629 |
| Email Address: | liyf@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| • Trade Name/Model: | 12MP Color LCD Monitor (C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)) |
|---|---|
| • Common Name: | 12MP Color LCD Monitor |
- 0 Classification Name: Medical Image Management and Processing System
- Regulation Number: 21 CFR 892.2050
- PGY 0 Product code:
- O Classification Panel: Radiology
- Device Class: ll O
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows:
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EIZO Corporation, 12MP Color LCD Monitor, RadiForce RX1270, RX1270-AR has been cleared by FDA through 510(k) No. K200485 (Decision Date - March 23, 2020).
5. Description of the Device [21 CFR 807.92(a) (4)]
The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6. Intended Use [21 CFR 807.92(a)(5)]
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
7. Indications for Use
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
| Panel characteristics: | |
|---|---|
| Screen technology | 31", TFT, color, LCD screen, AG type |
| Active area (H x V) | 652.68 x 435.12 mm |
| Pixel pitch | 0.1554 mm (H) x 0.1554 mm (V) |
| Resolution | 4200 x 2800 Pixels |
| Contrast ratio | 1050:1 (minimum), 1500:1 (typical) |
| Viewing angle (CR > 10) | Horizontal: 178° (typical) |
| Vertical: 178° (typical) | |
| Screen brightness | 1200cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Lifetime of backlight | 50000 hours (minimum) |
| Response time (Gray to Gray) | 14ms (typical ) |
| Color support | 1.07G |
| Power supply: | |
| Power connection | Power cord connector with protective conductor, |
| IEC60320-C14 | |
| Input voltage | AC 100-240V 50/60Hz |
| Current consumption | 2.4-1.0 A |
| Power consumption | ≤200W |
| Standby |