6MP Color LCD Monitor (C61W+)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is 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 {2}------------------------------------------------ #### 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) #### 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 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). {4}------------------------------------------------ ## 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).<br>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 | < 5 W | | | Inputs/outputs: | | | | DVI input | Dual link DVI-D socket | | | VGA input | For updating software | | | USB | For connecting external PC | | | DP input | Display Port socket | | | Control and connection: | | | | Front | 1 operation LED, 6 functional keys | | | Back | 3 USB port 2 DVI connector 2 DP connector 1 VGA connector 1 Ground 1 DC socket 1 Power switch | | | Mechanical characteristics: | | | | Housing components | Plastic | | | Ventilation openings | Natural heat radiation | | | Connector panel | On rear panel, under cover | | | Weight | 15.5 kg +/- 0.5 kg | | | Dimensions (W x H x D) in mm | 718.5 x 549.1 ~ 629.1 x 251.4 mm (with stand) | | | Climatic conditions: | | | | Working temperature | 0°C ... 40°C | | | Working humidity | 20% ... 80% Relative humidity, no condensation | | | Transport and storage<br>temperature | -20°C ... 60°C | | | Transport and storage humidity | 10% ... 90% Relative humidity, no condensation | | | Air pressure | 700 - 1060 hPa | | | Safety regulations: | | | | Safety standards | IEC60601-1, EN60601-1<br>ANSI/AAMI ES60601-1: 2005 + A2(R2012) + A1<br>CAN/CSA-C22.2 NO. 60601-1:14 | | | Protection class | Class III (adapter) | | | Degree of protection | IP20 | | | Conformity | CE according to MDD 93/42/EEC (Class I) | | | Electromagnetic compatibility: | | | | Noise immunity/interference<br>emissions | IEC 60601-1-2, EN 60601-1-2 | | | Dimension: | | | | With packing (W x H x D) | 814 x 606 x 327 mm | | | Weight: | | | | Gross weight | 18 kg | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92] #### 8.1 Intended uses: | ID | Comparison<br>Item | Proposed Device<br>6MP Color LCD Monitor<br>(C61W+) | Predicate Device<br>6MP Color LCD Monitor<br>(RX650) | |----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Intended Use | The 6MP Color LCD Monitor<br>(C61W+) is intended to be<br>used in displaying and viewing<br>digital images for review and<br>analysis by trained medical<br>practitioners. It does not<br>support the display of<br>mammography images for<br>diagnosis. | This product is intended to be<br>used in displaying and<br>viewing digital images for<br>review and analysis by<br>trained medical practitioners.<br>It does not support the display<br>of mammography images for<br>diagnosis. | #### Table 1 Intended Use Comparison #### 8.2 Comparison table #### Table 2 General Comparison | ID | Comparison<br>Item | Proposed Device<br>6MP Color LCD<br>Monitor (C61W+) | Predicate Device<br>6MP Color LCD<br>Monitor<br>(RX650) | Explanation<br>of Difference | | |------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--| | 2 | Display Performance/Specifications | | | | | | 2.1 | Screen<br>technology | TFT Color LCD Panel<br>(IPS) | TFT Color LCD Panel<br>(IPS) | - | | | 2.2 | Viewing angle<br>(H, V) | H:170°, V:170° | H:176°, V:176° | Different<br>screen<br>provided by<br>the different<br>manufacturer | | | 2.3 | Active screen<br>size | 654.4 x 408.6 mm | 645.5 mm x 403.0 mm | Different<br>screen<br>provided by<br>the different<br>manufacturer | | | 2.4 | Resolution | 6MP (3,280 x 2,048) | 6MP (3,280 x 2,048) | - | | | 2.5 | Aspect ratio | 16:10 | 16:10 | - | | | 2.6 | Pixel pitch | 0.197 mm x 0.197 mm | 0.197 mm x 0.197 mm | - | | | 2.7 | Typical<br>luminance | 800 cd/m² | 800 cd/m² | - | | | 2.8 | DICOM<br>calibrated<br>luminance | 500 cd/m² | 400 cd/m² | Different<br>screen<br>provided by<br>the different<br>manufacturer | | | 2.9 | Contrast ratio | 950:1 | 1000:1 | Different<br>screen<br>provided by<br>the different<br>manufacturer | | | 2.10 | Backlighting | LED | LED | - | | | 2.11 | Display Colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum) | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort):<br>1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77<br>million colors | - | | | 2.12 | Luminance<br>non-uniformity<br>compensation | Digital Uniformity<br>Equalizer | Digital Uniformity<br>Equalizer | - | | | 3 | Video Signal Input | | | | | | 3.1 | Input video<br>signals | DVI-D (dual link) x 2,<br>DisplayPort x 2<br>VGA x 1 | DVI-D (dual link) x 2,<br>DisplayPort x 2<br>(two inputs are<br>required) | Different<br>design<br>scheme | | | 3.2 | Scanning<br>Frequency<br>(H, V) | 31.5 - 120 kHz/29 - 61<br>Hz (VGA Text: 59 - 75<br>Hz)<br>Frame synchronous<br>mode: 29.5- 30.5Hz,<br>50 - 60 Hz | 31 - 129 kHz/29 - 61<br>Hz (VGA Text: 69 - 71<br>Hz)<br>Frame synchronous<br>mode: 29.5 - 30.5 Hz,<br>59 - 61 Hz | - | | | 4 | Power Related Specifications | | | | | | 4.1 | Power<br>Requirements | DC 24 V, 9.0 A | AC 100 - 120 V,<br>200 - 240 V: 50/60 Hz | The<br>difference<br>between<br>Built-in power<br>supply and<br>Built-out<br>power supply | | | 4.2 | Power<br>Consumption<br>/Save Mode | 160 W/less than 5 W | 225 W/ Less than 6 W | Different<br>design<br>scheme | | | 4.3 | Power<br>Management | DC Socket,<br>Power switch | DVI DMPM,<br>DisplayPort 1.1a | Different<br>design<br>scheme | | | 5 | Miscellaneous Features/Specifications | | | | | | 5.1 | QC software | Beacon Monitor<br>Manage | RadiCS | Different<br>design<br>scheme | | | 5.2 | Sensors | Backlight Sensor,<br>Integrated Front<br>Sensor,<br>Ambient Light Sensor | Backlight Sensor,<br>Integrated Front<br>Sensor,<br>Presence Sensor,<br>Ambient Light Sensor | - | | | 5.3 | USB<br>Ports/Standard | 1 upstream,<br>2 downstream / Rev.<br>2.0 | 1 upstream,<br>2 downstream / Rev.<br>2.0 | - | | | 5.4 | Dimensions<br>w/o stand<br>(W x H x D) | 698 x 470 x 78 mm | 692 x 466 x 109 mm | Different<br>housing<br>design due to<br>the different<br>panel size | | {8}------------------------------------------------ {9}------------------------------------------------ It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the C61W+. #### 8.3 Performance Testing The bench tests were performed on C61W+ as below. {10}------------------------------------------------ - 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+. #### 9. Conclusion [21 CFR 807.92(b) (3)] In accordance with the Federal Food, Drug 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 use of C61W+ is totally same as that of the predicatedevice. - The technological characteristics differences between C61W+ and RadiForce RX650 do not affect the safety and effectiveness, no new risk is raised. - Demonstrated by the bench tests, the display characteristics of C61W+ are equivalent to those of the predicate device.