(56 days)
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.
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.
The provided text describes K240310 for Shenzhen Beacon Display Technology Co., Ltd.'s LCD Monitors (C310S, G310S, C316S, G316S, C616W) but does not contain acceptance criteria or study details regarding AI/algorithm performance.
The submission focuses on establishing substantial equivalence to predicate devices through technical comparisons and bench testing of display characteristics. There is no mention of an AI/algorithm component requiring performance studies with human readers, ground truth establishment, or clinical evaluations.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving it meets them, as the provided text pertains to LCD monitors themselves, not an AI component.
The document does contain the following relevant information regarding the LCD monitors' performance:
The performance testing was done via bench tests and focused on the display characteristics of the monitors.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a pass/fail form with numerical targets. Instead, it states that the devices (C310S, G310S, C316S, G316S, C616W) were tested to verify "display characteristics equivalent to those of the predicate devices" and that they "meet DICOM Part 3.14 and other standards." The reported performance is implicitly shown through the comparison tables (Tables 1, 2, and 3) by comparing the proposed devices with their respective predicate devices.
Here's an example of some performance characteristics from the provided tables. For a full list, please refer to the "General Comparison" tables in the original document.
Example Table of Reported Device Performance (Partial - C310S/C316S Color LCD Monitors):
| Performance Characteristic | Acceptance Criteria (Implied: Equivalent to Predicate) | Reported Device Performance (C310S/C316S) | Predicate Device Performance (C32S+) |
|---|---|---|---|
| Native Resolution | 1536 x 2048 | 1536 x 2048 | 1536 x 2048 |
| Viewing Angle (H/V) | 178°/178° | 178°/178° | 178°/178° |
| Brightness (typical) | Equivalent to 1000 cd/m² (predicate) | 1100 cd/m² | 1000 cd/m² |
| Recommended brightness | Equivalent to 500 cd/m² (predicate) | 450 cd/m² | 500 cd/m² |
| Contrast Ratio (typical) | Equivalent to 1500:1 (predicate) | 2000:1 | 1500:1 |
| Conformance | Meet DICOM Part 3.14 and other standards | Met | Met |
Note: The "Explanation of Differences" column in the original tables addresses specific instances where the proposed device's performance differs numerically from the predicate but is considered substantially equivalent (e.g., "Different Panel" or "Different design scheme" for brightness/contrast differences, which are then justified by passing TG18 guideline tests).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the bench tests were performed on C310S, G310S, C316S, G316S, C616W," implying one or more units of each model. It does not mention a large sample size of images or cases, as this is a device for displaying images, not an image analysis algorithm.
- Data Provenance: Not applicable in the context of image data. The testing was conducted on the physical monitors themselves, measuring their optical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for evaluating display performance is based on established technical standards (e.g., DICOM Part 3.14, AAPM TG18 guideline) and objective measurements, not subjective expert interpretation of medical images on the device.
4. Adjudication method for the test set:
- Not applicable. Performance was assessed against objective technical specifications and standards using bench tests, not through human adjudication of diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI device. The submission does not describe an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used:
- Technical Standards and Objective Measurements: The "ground truth" for the display devices' performance is their conformance to established industry standards like DICOM Part 3.14 and the AAPM Task Group 18 (TG18) guideline for assessment of display performance. This includes measurements of spatial resolution (MTF), pixel defects, luminance characteristics (maximum, minimum, achievable, recommended), DICOM GSDF conformance, and color tracking.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
{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, DalangSubdistrict, 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 | < 100 W |
|---|---|
| Standby | ≤ 0.5 W |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| 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 60601-1-2EN 60601-1, EN 60601-1-2ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+A2:2021CAN/CSA-C22.2 NO. 60601-1:14+ A2:2022 |
| Conformity | CCC,CE,FCC,cTUVus,China energy |
| Dimension: |
{8}------------------------------------------------
| With packing (W x H x D) | 483 x 321 x 627 mm |
|---|---|
| Weight: | |
| Net weight | Approximate 8.2 ± 0.5 kg |
C316S Color LCD monitor
| 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: | |
| 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 60601-1-2EN 60601-1, EN 60601-1-2ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+A2:2021CAN/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 60601-1-2EN 60601-1, EN 60601-1-2ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ A2:2021CAN/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 60601-1-2EN 60601-1, EN 60601-1-2ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ A2:2021CAN/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 | <160W |
| Standby | < 0.5 W |
| Control and connection: | |
| Front | 1 operation LED, 6 functional keys |
| Back | Power switch * 1 AC socket * 1 DVI * 1 Display Port * 3 USB * 7 |
| Mechanical characteristics: | |
| Housing components | Plastic, Metal |
| Ventilation openings | Natural heat dissipation |
| Degree of protection | IP20 |
| Climatic conditions: | |
| Operational temperature | 0°C ~40°C |
| Operational 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 |
| Operational pressure | 700 hPa~1060 hPa |
| Safety regulations: | |
| Safety standards | IEC 60601-1, IEC 60601-1-2EN 60601-1, EN 60601-1-2ANSI/AAMI ES60601-1:2005+ A2:2010(R2012) +A1:2012+ A2:2021CAN/CSA-C22.2 NO. 60601-1:14+ A2:2022 |
| Conformity | CCC,CE,FCC,TUV,CB,CECP |
| Dimension: | |
| With packing (W x H x D) | 840 x 643 x321 mm |
| Weight: | |
| net weight | 18.7 ± 0.5 kg |
{15}------------------------------------------------
{16}------------------------------------------------
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Comparison table
| Table 1 General Comparison of C310S, C316S | ||||
|---|---|---|---|---|
| -- | -- | -------------------------------------------- | -- | -- |
| ID | ComparisonItem | Proposed Device | Predicate Device | Explanation ofDifferences | |
|---|---|---|---|---|---|
| C310S | C316S | C32S+ | |||
| 1.Display Performance/Specifications | |||||
| 1.1 | Displaytechnology | Color (IPS) | Color (IPS) | Color (IPS) | - |
| 1.2 | Screen size | 54.1cm/21.3"Aspect ratio:3:4 | 54.1cm/21.3"Aspect ratio:3:4 | 54.1cm/21.3"Aspect ratio:3:4 | - |
| 1.3 | Viewing angle(H/V) | 178°/178° | 178°/178° | 178°/178° | - |
| 1.4 | Nativeresolution | 1536 x 2048 | 1536 x 2048 | 1536 x 2048 | - |
| 1.5 | Viewable imagesize (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | 324.86 x 433.15 mm | - |
| 1.6 | Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | - |
| 1.7 | Response time(typical) | 25 ms (on / off) | 25 ms (on / off) | 25 ms (on / off) | - |
| 1.8 | Brightness(typical) | 1100cd/m² | 1100cd/m² | 1000 cd/m² | Different Panel |
| 1.9 | Recommendedbrightness | 450 cd/m² | 450 cd/m² | 500 cd/m² | Different design scheme |
| 1.10 | Contrast ratio(typical) | 2000:1 | 2000:1 | 1500:1 | Different Panel |
| 1.11 | Backlight type | LED | LED | LED | |
| 1.12 | Display colors | 10-bit (DisplayPort):1.073 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones | 10-bit (DisplayPort):1.073 billion1024 from a palette of16,384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones | 10-bit (DisplayPort):1.073 billion1024 from a palette of16.384 tones8-bit(DVI): 16.77million 256 from apalette of 16,384tones | - |
| 2.Video Signals | |||||
| 2.1 | Input videosignals | DVI-D (dual link) x 1,DisplayPort x 1 | DVI-D (dual link) x 1,DisplayPort x 2 | DVI-D (dual link) x 1,DisplayPort x 1 | Different design scheme |
| 2.2 | Digital ScanningFrequency (H, V) | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | 31 - 97 kHz/59 - 61 Hz | Different design scheme |
| 2.3 | Videobandwidth | DVI: 214.25 MHzDisplayPort: 214.25MHz | DVI: 216 MHzDisplayPort: 216 MHz | DVI: 216 MHzDisplayPort: 216 MHz | Different design scheme |
| 3.Power Related Specifications | |||||
| 3.1 | PowerRequirements | DC 24V/ 5.0A | DC 24V/ 5.0A | DC 12 V / 6.67 A | Different design scheme |
| 3.2 | Maximum powerconsumption | 100 W | 100 W | 80 W | Different design scheme |
| 3.3 | Power savemode | Less than or equal to0.5 W | Less than or equal to0.5 W | Less than 5 W | Different design scheme |
| VESA DPMS and | VESA DPMS and | ||||
| 3.4 | Power | EPA power saving | EPA power saving | DVI DMPM, | - |
| Management | management,DisplayPort 1.2 | management,DisplayPort 1.2 | DisplayPort 1.2 | ||
| DisplayPort 1.2 | DisplayPort 1.2 | ||||
| 4.Miscellaneous Features/Specifications | |||||
| 4.1 | Quality-controlSoftware | Beacon MonitorManage | Beacon MonitorManage | Beacon MonitorManage | - |
| 4.2 | Sensors | Backlight sensorIntegrated front sensorAmbient sensor | Backlight sensorIntegrated front sensorAmbient sensorPresence sensorGravity sensor | Backlight sensorIntegrated front sensorAmbient light sensor | Different design scheme |
| 4.3 | USB Ports | 2 USB Upstream Port4 USB DownstreamPort | 1 USB-A2 USB Upstream Port4 USB DownstreamPort | USB Upstream Port1USB DownstreamPort2 | Different design scheme |
| 4.4 | Brightnessstabilization | Yes | Yes | Yes | - |
| 4.5 | Net weight | $8.2 \pm 0.5$ kg | $8.6 \pm 0.5$ kg | 9.5 | Different weight due todifferent components andparts |
| 4.6 | Dimensions w/ostand (W x H xD) | 342.5 x 520.26 ~620.26 x 224 | 342.5 x 520.26 ~620.26 x 224 | 369 x 220 x 511.5 ~596.15 | Different housing designdue to the different panelsize |
| 5. Indications for Use | |||||
| 5.1 | Indications forUse | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | This product isindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.This product is notintended formammography. | The 3MP Color LCDMonitors C32S+ areindicated for use indisplaying radiologicalimages for review,analysis, anddiagnosis by trainedmedical practitioners.The displays are notintended formammography. |
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Table 2 General Comparison of G310S, G316S
| ID | Comparison Item | Proposed Device | Predicate Device | Explanation of Differences | |
|---|---|---|---|---|---|
| G310S | G316S | G32S+ | |||
| 1.Display Performance/Specifications | |||||
| 1.1 | Display technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | - |
| 1.2 | Screen size | 54.1 cm / 21.3" (541 mm diagonal) | 54.1 cm / 21.3" (541 mm diagonal) | 54 cm / 21.3" (541 mm diagonal) | - |
| 1.3 | Viewing angle (H/V) | 178°/178° | 178°/178° | 170°/170° | Different Panel |
| 1.4 | Native resolution | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | 1536 x 2048 (3:4 aspect ratio) | - |
| 1.5 | Viewable image size (H x V) | 324.86 x 433.15 mm | 324.86 x 433.15 mm | 324.86 x 433.15 mm | - |
| 0.2115 mm (H) x0.2115 mm (V) | 0.2115 mm (H) x0.2115 mm (V) | 0.2115 mm (H) x0.2115 mm (V) | |||
| 1.6 | Pixel pitch | ||||
| 1.7 | Response time(typical) | 25 ms (On/Off) | 25 ms (On/Off) | 28 ms (On/Off) | Different Panel |
| 1.8 | Brightness(typical) | 2500 cd/m² | 2500 cd/m² | 2000 cd/m² | Different Panel |
| 1.9 | Recommendedbrightness | 450 cd/m² | 450 cd/m² | 500 cd/m² | Different design scheme |
| 1.10 | Contrast ratio(typical) | 2500:1 | 2500:1 | 1500:1 | Different Panel |
| 1.11 | Backlight type | LED | LED | LED | - |
| 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones | 10-bit (DisplayPort):1,024 from a paletteof 16,384 tones | - | ||
| 1.12 | GrayscaleTones | 8-bit (DVI): 256 from apalette of 16,384tones | 8-bit (DVI): 256 from apalette of 16,384tones | 8-bit (DVI): 256 from apalette of 16,384tones | - |
| 2.Video Signals | |||||
| 2.1 | Input videosignals | DVI-D (dual link) x 1DisplayPort x 1 | DVI-D (dual link) x 1DisplayPort x 1 | DVI-D (dual link) x 1DisplayPort x 1 | - |
| 2.2 | Digital ScanningFrequency (H, V) | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | Landscape:Horizontal:126.327KHzVertical: 59.956Hz | 31 - 97 kHz, 60 - 70 Hz | Different design scheme |
| 2.3 | Dot Clock | DVI: 214.25 MHzDisplayPort: 214.25 MHz | DVI: 216 MHzDisplayPort: 216 MHz | 216 MHz | Different design scheme |
| 3.Power Related Specifications | |||||
| 3.1 | PowerRequirements | DC 24V/ 5.0A | DC 24V/ 5.0A | DC 12 V / 6.67 A | Different design scheme |
| 3.2 | Maximum powerconsumption | 60 W | 60 W | 50 W | Different design scheme |
| 3.3 | Power savemode | Less than or equal to0.5 W | Less than or equal to0.5 W | Less than 5 W | Different design scheme |
| 3.4 | PowerManagement | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | VESA DPMS and EPApower savingmanagement,DisplayPort 1.2 | DVI DMPM,DisplayPort 1.2 | - |
| 4.1 | Quality-controlprocedures | Beacon MonitorManage | Beacon MonitorManage | Beacon MonitorManage | - |
| 4.2 | Sensors | Backlight sensorIntegrated front sensorAmbient sensor | Backlight sensorIntegrated front sensorAmbient sensorPresence sensorGravity sensor | Backlight SensorIntegrated FrontSensorAmbient Light Sensor | Different design scheme |
| 4.3 | USB Ports | 2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | 1 USB-A2 USB Upstream Port4 USB DownstreamPort/ Rev. 2.0 | 1 upstream2 downstream / Rev.2.0 | Different design scheme |
| 4.4 | Brightnessstabilization | Yes | Yes | Yes | - |
| 4.5 | Net weight | $8.2 \pm 0.5$ | $8.6 \pm 0.5$ | 9.0 kg | Different weight duetodifferent components andparts |
| 4.6 | Dimensions w/ostand (W x H xD) | 342.5 x 520.26 ~620.26 x 224 | 342.5 x 520.26 ~620.26 x 224 | 369 x 511.15 ~ 596.15x 220 | Different housing designdue to the different panelsize |
| 5. Indications for Use | |||||
| This product isintended to be used indisplaying and viewingdigital images fordiagnosis of X-ray orMRI, etc. by trainedmedical practitioners.This product is notspecified for digitalmammographysystems. | This product isintended to be used indisplaying and viewingdigital images fordiagnosis of X-ray orMRI, etc. by trainedmedical practitioners.This product is notspecified for digitalmammographysystems. | The 3MPMonochrome LCDMonitors G32S+ areintended to be used indisplaying and viewingdigital images fordiagnosis of X-ray orMRI, etc. by trainedmedical practitioners.The devices are notspecified for digitalmammographysystems. | |||
| 5.1 | Indications for Use |
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LCD Monitors C310S, G310S, C316S, G316S, C616W
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LCD Monitors C310S, G310S, C316S, G316S, C616W
510(k) Submission
Table 3 General Comparison of C616W
| ID | ComparisonItem | Proposed DeviceC616W | Predicate DeviceC61W+ | Explanation of Differences |
|---|---|---|---|---|
| 1.Display Performance/Specifications | ||||
| 1.1 | Display technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| 1.2 | Screen size | 30" (Aspect Ratio 16:10) | 30" (Aspect Ratio 16:10) | - |
| 1.3 | Viewing angle (H/V) | H: 178°; V: 178° | H:170°, V:170° | Different Panel |
| 1.4 | Native resolution | $3280 \times 2080$ | $3280 \times 2048$ | Different Panel |
| 1.5 | Viewable image size(H x V) | 645.504 x 409.344 mm | 654.4 x 408.6 mm | - |
| 1.6 | Pixel pitch | 0.197 mm (H) x 0.197 mm (V) | 0.197 mm (H) x 0.197 mm (V) | - |
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| 1.7 | Response time(typical) | 28ms | 30ms | Different Panel | |
|---|---|---|---|---|---|
| 1.8 | Brightness (typical) | 1300cd/m² | 800 cd/m² | Different design scheme | |
| 1.9 | Recommendedbrightness | 450 cd/m² | 500 cd/m² | - | |
| 1.10 | Contrast ratio (typical) | 2000:1 | 950:1 | - | |
| 1.11 | Backlight type | LED | LED | - | |
| 1.12 | Display colors | 10bit | From a palette of 68 billioncolors:- 10-bit (DisplayPort):1.07 billion colors(maximum) | Tone between the predicatedevice and our proposeddevices are different. But theypass the exams in AAPM-TG184.3 "Luminance Response"Therefore, they are equivalentto the predicate device. | |
| 2.Video Signals | |||||
| 2.1 | Input video signals | DVI-D (dual link) x 1,DisplayPort x 2 | DVI-D (dual link) x 2,DisplayPort x 2VGA x 1 | Different design scheme | |
| 2.2 | Digital ScanningFrequency (H, V) | 1P DVI:Horizontal: 63.3KHzVertical: 30.0Hz1P DPHorizontal: 128.3KHzVertical: 60Hz2P DVI:Horizontal: 128.3KHzVertical: 60.0Hz2P DPHorizontal: 128.3KHzVertical: 60.0Hz | 31.5 - 120 kHz/29 - 61Hz(VGA Text: 59 - 75Hz)Frame synchronous mode:29.5- 30.5Hz, 50 - 60 Hz | Different design scheme | |
| 2.3 | Video bandwidth | DVI: 217.75/ 441.5231.00 MHzDisplayPort: 441.5/ 231.00MHz | - | Different design scheme | |
| 3.Power Related Specifications | |||||
| 3.1 | Power Requirements | 100-240VAC 50/60Hz | DC 24 V, 9.0 A | Difference between built-inpower supply and built-outpower supply | |
| 3.2 | Maximum powerconsumption | 160W | 160W | - | |
| 3.3 | Power save mode | Less than 0.5 W | Less than 0.5 W | - | |
| 3.4 | Power Management | VESA DPMS and EPA powersaving management,DisplayPort 1.2 | DC Socket,Power switch | Different design scheme | |
| 4.Miscellaneous Features/Specifications | |||||
| 4.1 | Quality-controlSoftware | Beacon Monitor Manage | Beacon Monitor Manage | - | |
| 4.2 | Sensors | Integrated front sensorAmbient sensorPresence sensor | Backlight Sensor,Integrated Front Sensor,Ambient Light Senso | Different design scheme | |
| 4.3 | USB Ports | 1 USB-12 USB Upstream Port4 USB Downstream Port/Rev. 2.0 | 1 upstream,2 downstream / Rev. 2.0 | Different design scheme | |
| 4.4 | Brightnessstabilization | Yes | Yes | - | |
| 4.5 | Net weight | 18.7 kg | 15.5 kg | Different weight due to differentcomponents and parts | |
| 4.6 | Dimensions w/o stand(W x H x D) | With base: 687.14 x 531.11 ~631.11 x 264.00 mm | 698 x 470 x 78 mm | Different housing design due tothe different panel size | |
| 5. Indications for Use | |||||
| 5.1 | Indications for Use | This product is indicated foruse in displaying radiologicalimages for review, analysis,and diagnosis by trainedmedical practitioners. Thisproduct is not intended formammography. | The 6MP Color LCD Monitor(C61W+) is intended to beused in displaying andviewing digital images forreview and analysis by trainedmedical practitioners. It doesnot support the display ofmammography images fordiagnosis |
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LCD Monitors C310S, G310S, C316S, G316S, C616W
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LCD Monitors C310S, G310S, C316S, G316S, C616W
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The technological characteristics differences discussed above do not affect the safety and the effectiveness of the C310S, G310S, C316S, G316S, C616W.
8.2 Performance Testing
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.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Druq 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 uses of proposed devices (C310S, C316S, C316S, C616W) are equivalent to the predicate devices.
- The technological characteristics differences between proposed devices (C310S, G310S, C316S, G316S, C616W) and the predicate devices do not affect the safety
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and effectiveness, so no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of proposed devices (C310S, G310S, C316S, G316S, C616W) are equivalent to those of the predicate devices.
§ 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).