CW60N

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WIDE Corporation % Josh Baker Consultant OT Consulting Inc. 33781 Bayside Lane DANA POINT CA 92629 October 31, 2022 # Re: K222722 Trade/Device Name: CW60N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: September 8, 2022 Received: September 8, 2022 Dear Josh Baker: 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 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 {1}------------------------------------------------ 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 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. Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222722 Device Name CW60N #### Indications for Use (Describe) CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis. Type of Use (Select one or both, as applicable) | <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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 [As required by 21 CFR 807.92] This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92 # 1. Date Prepared [21 CFR 807.92(a) (1)] 06/13/2022 #### 2. Submitter's Information [21 CFR 807.92(a) (1)] | Name of Sponsor: | WIDE Corporation. | |-----------------------|--------------------------------------------------------------------------------------------------------| | Address: | 15F, The First Tower III, 602, Dongtangiheung-Ro,<br>Hwaseong-Si, Gyeonggi-Do 18469, Republic of Korea | | Contact Name: | YeoJin Yun | | | Telephone #: +82-31-218-1675 | | | Fax #: +82-31-376-9600 | | | Email: yyjin@widecorp.com | | Registration Number: | 3004082357 | | Name of Manufacturer: | Same as Sponsor | | 510(k) Contact Person | Josh Baker – Consultant, OT Consulting Inc.<br>33781 Bayside Lane, Dana Point, California 92629 USA | | | Tel: 714-788-8152 | | | Email: josh@otconsulting.tech | #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)] | Model Name: | CW60N | |----------------------|------------------------------------------------| | Common Name: | TFT LCD Medical Monitor System | | Classification Name: | Medical image management and processing system | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | PGY | | Device Class: | 2 | | Review Panel: | Radiology | # 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] | 510(k) Number: | K163335 | |----------------|--------------------------------------------------| | Applicant: | EIZO CORPORATION | | Model Name: | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR | | Common Name: | 6MP Color LCD Monitor | 510(k) Summary 1/4 {4}------------------------------------------------ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2 #### 5. Description of the Device [21 CFR 807.92(a) (4)] CW60N LCD Monitor is intended to display high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images. EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards. EzCal is packed with the display. #### 6. Intended Use [21 CFR 807.92(a) (5)] CW60N LCD Monitor is intended to be used in displaying and viewing digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis. #### 7. Technological Characteristics [21 CFR 807.92(a) (6)] The table below presents comparisons between the subject device (CW60N) and the predicate device (K163335): | Attributes | Predicate Device | Subject Device | Discussion<br>of<br>Differences | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Product | RadiForce RX660,<br>RadiForce RX660-AR | CW60N | - | | Screen<br>technology | TFT Color<br>LCD Panel (IPS) | TFT Color<br>LCD Panel (IPS) | - | | Viewing angle (H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - | | Resolution | 6MP (3,280 x 2,048) | 6MP (3,280 x 2,048) | - | | Aspect ratio | 16 : 10 | 16 : 10 | - | | Active screen size | 645.5 mm x 403.0 mm | 645.504 mm x<br>403.0464 mm | Provided by the panel<br>manufacturers. | | Pixel pitch | 0.1968 mm x 0.1968<br>mm | 0.197 mm x 0.197<br>Mm | Provided by the panel<br>manufacturers. | | Maximum luminance | 1,000 cd/m² | 1,300 cd/m² | Provided by the panel<br>manufacturers. | | DICOM calibrated<br>luminance | 500 cd/m² | 500 cd/m² | - | | Contrast ratio(typical) | 1500 : 1 | 2000 : 1 | Provided by the panel<br>manufacturers. | | Response<br>Time(typical) | 25ms (On/Off) | 28ms (On/Off) | Provided by the panel<br>manufacturers. | | Backlighting | LED | LED | - | | Display Colors | From a palette of 68<br>billion colors:<br>- 10-bit (DisplayPort): | From a palette of 68<br>billion colors:<br>- 10-bit : 1.07 billion | - | | | 1.07 billion colors<br>(maximum)<br>- 8-bit colors: 16.77 million colors | colors (maximum) | | | Luminance Non-<br>uniformity<br>compensation | Digital Uniformity<br>Equalizer | Luminance Uniformity<br>Correction | It is only a difference in<br>terms of each<br>manufacturer, but the<br>functions are similar. | | Input video signals | DVI-D (dual link) x 1,<br>DisplayPort x 2 | DisplayPort x 1 | Differences by<br>manufacturers. | | Output video signals | DisplayPort x 1 (daisy<br>chain) | - | Differences by<br>manufacturers. | | Scanning Frequency<br>(H / V) | 31 - 127 kHz / 22 - 61 Hz<br>(VGA Text: 69 - 71<br>Hz)<br>Frame synchronous<br>mode:<br>29.5 - 30.5 Hz, 59 - 61<br>Hz | DisplayPort<br>115.5KHz, 55Hz | : Differences by<br>manufacturers. | | Power<br>Requirements | AC 100 - 240 V:<br>50 / 60 Hz | AC 100 - 240 V:<br>50 / 60 Hz | - | | Power<br>Consumption /<br>Save Mode | 190 W / Less than 1.6<br>W | 180 W / Less than 20<br>W | Differences by<br>manufacturers. | | Power<br>Management | DVI DMPM,<br>DisplayPort 1.2a | DisplayPort 1.2a | - | | QC software | RadiCS | EzCal | It is only a difference in<br>terms of each<br>manufacturer, but the<br>functions are similar. | | Sensors | Backlight Sensor,<br>Integrated Front<br>Sensor,<br>Presence Sensor,<br>Ambient Light Sensor | IQ Sensor,<br>Human Sensor,<br>Ambient Light Sensor | It is only a difference in<br>terms of each<br>manufacturer, but the<br>functions are similar. | | USB Ports /<br>Standard | 2 upstream,<br>3 downstream / Rev.<br>2.0 | 1 upstream,<br>2 downstream / Rev.<br>3.0 | Differences by<br>manufacturers. | | Dimensions<br>(W x H x D) | 682.5 x 441 x 88 mm<br>(w/o stand) | 692.0 x 642.7 x 283.0<br>mm<br>(w stand) | Different housing<br>design. | 510(k) Summary 2/4 {5}------------------------------------------------ CW60N Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness. ## 8. Summary of Non-Clinical Data CW60N comply with the following international and FDA-recognized consensus standards: {6}------------------------------------------------ | IEC 60601-1: | Medical Electrical Equipment -- Part 1: General<br>Requirements For Basic Safety And Essential Performance | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General<br>Requirements For Basic Safety And Essential Performance -<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements And Tests | The bench tests below were performed on the CW60N following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017. • Test Item Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF #### 9. Summary of Clinical Data No clinical studies were considered necessary and performed. #### 10. Conclusion [21 CFR 807.92(b) (3)] Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, the safety of the subject device was validated through tests including ANSI/AAMI ES 60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests. The results of these tests demonstrate that CW60N meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.