(56 days)
Not Found
No
The document describes medical display monitors and their technical specifications, focusing on image display quality and adherence to standards like DICOM. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a display monitor used for viewing radiological images for diagnosis, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners" and "intended to be used in displaying digital images for diagnosis". This clearly indicates their role in the diagnostic process.
No
The device description explicitly details physical hardware components (LCD monitors, LED backlight panels, main boards) and performance studies related to these hardware characteristics (spatial resolution, pixel defects, luminance, etc.). While it mentions a "Medical image management and processing system," the core device being described and tested is the display hardware.
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 to visualize medical images, not a device used to perform tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the technical specifications of the monitors for displaying images (LCD type, resolution, calibration to DICOM, brightness stabilization, anti-glare). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling, or any other elements typically associated with in vitro diagnostic devices.
The device is a medical image display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
G310S and G316S are intended to be used in displaying 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 LCD Monitors C310S, G310S, C316S, G316S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography.
These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography. This product has been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle. G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle. C310S and G310S have the same main board and design principle. C316S and G316S have the same main board and design principle.
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)
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 C310S, G310S, C316S, G316S, C616W as below.
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults
- Visual check of presence or absence of miscellaneous artifacts on the display screen ● as specified in TG18 guideline
- Measure the temporal response using the typical data provided by the panel manufacturer
- Meausure the maximum, minimum, achievable, and recommended luminance
- Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 quideline)
- Measurement of Color tracking (primary colors and color gamut)
The test results showed that C310S, G310S, C316S, G316S, C616W are with display characteristics equivalent to those of the predicate devices.
No animal or clinical testing is needed for C310S, C316S, G316S, C616W.
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
FDA U.S. FOOD & DRUG
ADMINISTRATION
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: K240310
Trade/Device Name: LCD Monitors C310S, G310S, C316S, G316S, C616W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: February 2, 2024 Received: February 2, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
March 29, 2024
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Saml 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
LCD Monitors C310S, G310S, C316S, G316S, C616W
Indications for Use (Describe)
C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
G310S and G316S are intended to be used in displaying 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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
510 (k) Summary
4
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Feb 29, 2024
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: 3MP Color LCD Monitors C310S, C316S; 3MP Monochrome LCD Monitors G310S, G316S; 6MP Color LCD Monitor C616W. Common Name: LCD Monitors C310S, G310S, C316S, G316S, C616W ● ● Classification Name: Medical image management and processing system Regulation Number: 21 CFR 892.2050 ● PGY ● Product code: ● Classification Panel: Radiology ● Device Class: ll
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
5
The identified predicate within this submission is as follows:
Shenzhen Beacon Display Technology Co., Ltd., 3MP Color LCD Monitors C32S+, 3MP Monochrome LCD Monitors G32S+has been cleared by FDA through 510(k) No. K201211 (Decision Date - 09/03/2020).
Shenzhen Beacon Display Technology Co., Ltd., 6MP Color LCD Monitor (C61W+) has been cleared by FDA through 510(k) No. K182291 (Decision Date - 11/20/2018).
5. Description of the Device [21 CFR 807.92(a) (4)]
3MP LCD Monitors C310S, G310S, C316S, G316S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography.
These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1536 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
6MP Color LCD Monitor C616W is a 30-inch TFT LCD monitor, which is specifically designed to provide the high definition image output for general radiography. This product has been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3280 x 2080. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
C310S and C316S have the same color LCD panel and similar functionality. For C310S and C316S, the difference is the main board and design principle. G310S and G316S have the same monochrome LCD panel and similar functionality. For G310S and G316S, the difference is the main board and design principle. C310S and G310S have the same main board and design principle. C316S and G316S have the same main board and design principle.
6
6. Indications for use
C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
G310S and G316S 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.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Panel characteristics : | |
|---|---|
| Screen technology | 21.3", TFT, color, LCD screen, AG type |
| Active area(H x V) | 324.86(H) x 433.15(V) mm |
| Pixel pitch | 0.2115 (per one triad) x 0.2115 mm |
| Resolution | 1536(x3) x 2048 |
| Contrast ratio | 1600:1 (Minimum), 2000:1 (Typical) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical) |
| Vertical: 178° (Typical) | |
| Screen brightness | 1100cd/m² (Typical) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Lifetime of backlight | 50000 hours(Minimum) |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| Power supply : | |
| Line voltage | DC 24 V |
| Current consumption | 5.0 A |
C310S Color LCD monitor
510(k) Summary
7
| Power consumption | 10) | Horizontal: 178° (Typical)
Vertical: 178° (Typical) |
| Screen brightness | 1100cd/m² (Typical) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Lifetime of backlight | 50000 hours (Minimum) |
| Response time (TR+TF) | 11 + 14 ms (typical) |
| Color support | 1.07G |
| Power supply: | |
| Power connection | Adapter |
| Output | +24VDC, 5.0A |
| Power consumption: | |
| Normal Mode | 100W (Maximum) |
| Standby Mode | 0.5 W (Maximum) |
| Control and connection: | |
9
| Front | 1 operation LED, 6 functional keys |
|---|---|
| Back | Power switch1 DC Input1 DVI-D1 DP2 DP-OUT1 USB-A1 USB Upstream Port2 USB Downstream Port4 |
| Mechanical characteristics: | |
|---|---|
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1, IEC 60601-1-2 |
| EN 60601-1, EN 60601-1-2 | |
| ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ | |
| A2:2021 | |
| CAN/CSA-C22.2 NO. 60601-1:14+ A2:2022 | |
| Conformity | CCC,CE,FCC,cTUVus,Energy Conservation Certification |
| Dimension: | |
| With packing(W x H x D) | 483 x 321 x 627 mm |
| Weight: |
10
Approximate 8.6 ± 0.5 kg
| Panel characteristics: | |
|---|---|
| Screen technology | 21.3", TFT, grayscale, 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 | 2500:1 (typical), 2000:1 (minimal) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical) |
| Vertical: 178° (Typical) | |
| Screen brightness | 2500 cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time (TR+TF) | 12 + 13 ms (typical) |
| Power supply: | |
| Power connection | Adapter |
| Input | 100~240V, 1.4 ~ 0.7A, 50/60Hz |
| Output | +24VDC, 5.0A |
| Power consumption: | |
| Normal Mode | 60W (Maximum) |
| Standby Mode | 0.5 W (Maximum) |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
11
| Back | Power switch1 DVI-D1 DP1 USB Upstream Port2 USB Downstream Port*4 |
|---|---|
| ------ | ----------------------------------------------------------------------- |
| Mechanical characteristics: | |
|---|---|
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1, IEC 60601-1-2 |
| EN 60601-1, EN 60601-1-2 | |
| ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ A2:2021 | |
| CAN/CSA-C22.2 NO. 60601-1:14+ A2:2022 | |
| Conformity | CCC,CE,FCC,cTUVus,China energy |
| Dimension: | |
| With packing (W x H x D) | 483 x 321 x 627 mm |
| Weight: | |
| Net weight | Approximate $8.2 \pm 0.5$ kg |
G316S Monochrome LCD Monitor
12
| Panel characteristics: | |
|---|---|
| Screen technology | 21.3", TFT, grayscale, 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 | 2500:1 (typical), 2000:1 (minimal) |
| Viewing angle(CR > 10) | Horizontal: 178° (Typical) |
| Vertical: 178° (Typical) | |
| Screen brightness | 2500 cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LEDs |
| Lifetime of backlight | 50,000 hours |
| Response time(TR+TF) | 12 + 13 ms (typical) |
| Power supply: | |
| Power connection | Adapter |
| Output | +24VDC, 5.0A |
| Power consumption: | |
| Normal Mode | 60W (Maximum) |
| Standby Mode | 0.5 W (Maximum) |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch1 DC Input1 DVI-D1 DP2 DP-OUT1 USB-A1 USB Upstream Port2 USB Downstream Port4 |
13
| Mechanical characteristics: | |
|---|---|
| Housing components | Plastic |
| Ventilation openings | Natural heat radiation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Working temperature | 0°C - 40°C |
| Working humidity | 15% - 85% Relative humidity, no condensation |
| Transport and storage temperature | -20°C - 60°C |
| Transport and storage humidity | 10% - 90% Relative humidity, no condensation |
| Air pressure | 700hPa - 1060hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1, IEC 60601-1-2 |
| EN 60601-1, EN 60601-1-2 | |
| ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ A2:2021 | |
| CAN/CSA-C22.2 NO. 60601-1:14+ A2:2022 | |
| Conformity | CCC,CE,FCC,cTUVus,Energy Conservation Certification |
| Dimension: | |
| With packing(W x H x D) | 483 x 321 x 627 mm |
| Weight: | |
| Net weight | Approximate 8.6 ± 0.5 kg |
C616W Color LCD monitor
14
| Panel characteristics: | |
|---|---|
| Screen technology | 30", TFT, color, LCD screen, AG type, 3H hard coating |
| Active area (H x V) | 645.504 x 409.344 mm |
| Pixel pitch | 0.197 mm (H) x 0.197 mm (V) |
| Resolution | 3280 x 2080 Pixels |
| Contrast ratio | 1400:1 (minimum), 2000:1 (typical) |
| Viewing angle (CR > 10) | Horizontal: 178° (typical) |
| Vertical: 178° (typical) | |
| Screen brightness | 1300 cd/m² (typical) |
| Refresh rate | 60 Hz |
| Backlighting | LED |
| Lifetime of backlight | 50000 hours (minimum) |
| Response time (TR + TF) | 13+15 ms (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 |