CX50N

K222719 · Wide Corporation · PGY · May 9, 2023 · Radiology

Device Facts

• Record ID: K222719
• Device Name: CX50N
• Applicant: Wide Corporation
• Product Code: PGY · Radiology
• Decision Date: May 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CX50N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

Device Story

CX50N is a 21.3-inch TFT LCD medical monitor for PACS and radiology systems; displays high-resolution color and grayscale medical images. Used by trained medical practitioners in clinical settings for review and analysis of digital mammography and breast tomosynthesis images. Device incorporates backlight, IQ, and ambient light sensors to maintain image quality. Calibration software (EzCal v.2) enables modification of display output to meet DICOM Part 14 GSDF and industry standards. Output allows clinicians to visualize diagnostic images for clinical decision-making; benefits include high-fidelity visualization of breast imaging data.

Clinical Evidence

No clinical studies were performed. Effectiveness was validated through bench testing, including pixel defects, artifacts, luminance, reflection, uniformity, veiling glare, color tracking, gray tracking, and MTF, following the FDA guidance 'Display Devices for Diagnostic Radiology'.

Technological Characteristics

21.3" TFT LCD monitor; 2560 x 2048 resolution; 0.165 mm pixel pitch; 1,150 cd/m² max luminance; 2000:1 contrast ratio. Connectivity: DVI-I, DisplayPort, USB 3.0. Sensors: Backlight, IQ, and Ambient Light. Power: 100-240 VAC. Standards: IEC 60601-1, IEC 60601-1-2. Calibration via EzCal v.2 software.

Indications for Use

Indicated for trained medical practitioners for the display, review, and analysis of digital medical images, specifically for digital mammography and digital breast tomosynthesis applications.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• CX50N(CX50YQS) (K170783)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

WIDE Corporation % Mr. Josh Baker Consultant OT Consulting Inc. 33781 Bayside Lane DANA POINT CA 92629

Re: K222719

May 9, 2023

Trade/Device Name: CX50N 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 Mr. 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222719

Device Name CX50N

#### Indications for Use (Describe)

CX50N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary Submission number: K222719

[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 #: [phone] |
| | Fax #: [phone] |
| | Email: [e-mail] |
| Registration Number: | 3004082357 |
| Name of Manufacturer: | Same as Sponsor |
| 510(k) Contact Person | Josh Baker – Consultant, OT Consulting Inc. |
| | 33781 Bayside Lane, Dana Point, California 92629 USA |
| | Tel: [phone] |
| | Email: [e-mail] |

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

| Model Name: | CX50N |
|----------------------|------------------------------------------------|
| 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: K170783 WIDE Corporation Applicant:

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| Model Name: | CX50N(CX50YQS) |
|----------------------|---------------------------------------------|
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Picture archiving and communications system |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |

5. Description of the Device [21 CFR 807.92(a) (4)]

CX50N LCD Monitor is intended to provide 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, reviewing, and analysis 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.

CX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

6. Intended Use [21 CFR 807.92(a) (5)]

CX50N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

7. Technological Characteristics [21 CFR 807.92(a) (6)]

The table below presents comparisons between the subject device (CX50N) and the predicate device (K170783):

| Attributes | Predicate Device | Subject Device | Discussion of<br>Differences |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product | CX50N(CX50YQS) | CX50N | - |
| Intended Use | The CX50N(CX50YQS)<br>LCD Monitor System is<br>intended to be used in<br>displaying and viewing<br>digital medical images for<br>review and analysis by<br>trained medical<br>practitioners. It is<br>specifically designed for<br>digital mammography<br>applications and digital<br>breast tomosynthesis<br>applications. | CX50N LCD Monitor<br>System is intended to be<br>used in displaying and<br>viewing digital medical<br>images for review and<br>analysis by trained<br>medical practitioners. It<br>is specifically designed<br>for digital<br>mammography<br>applications and digital<br>breast tomosynthesis<br>applications. | - |
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| LCD Panel size | 21.3" | 21.3" | - |
| Resolution | 2560 x 2048 | 2560 x 2048 | - |
| Pixel pitch | 0.165 mm x 0.165mm | 0.165 mm x 0.165mm | - |
| Maximum luminance | 1,200 cd/m² | 1,150 cd/m² | Provided by the panel<br>manufacturers. |

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| Contrast Ratio | 1500 : 1 | 2000 : 1 | Provided by the panel<br>manufacturers. |
|-------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Input signal | DVI-I, DisplayPort | DVI-I, DisplayPort | - |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz | - |
| Color/Monochrome | Color | Color | - |
| QC software | Lumical Advanced | EzCal | It is only a difference<br>in terms of each QC<br>software, but the<br>functions are similar. |
| Firmware | Version: N1220_221229 | Version: N1220_221229 | No change of the<br>firmware. |
| Luminance Non-<br>uniformity compensation | Luminance Uniformity<br>Correction | Luminance Uniformity<br>Correction | - |
| Sensors | Backlight Sensor,<br>IQ Sensor,<br>Ambient Light Sensor | Backlight Sensor,<br>IQ Sensor,<br>Ambient Light Sensor | - |
| USB Ports /<br>Standard | 1 upstream,<br>3 downstream / Rev. 3.0 | 1 upstream,<br>3 downstream / Rev. 3.0 | - |
| Dimensions<br>(w stand)<br>(W x H x D) | 390.3 x 520.1 x 248.8 mm | 390.3 x 520.1 x 248.8 mm | - |

The subject monitor model CX50N device is an updated version of the predicate CX50N (CX50YQS) for the max luminance (from 1,200cd/m2 to 1,150cd/m2) with the improvement of the contrast ratio (from 1,500:1 to 2,000:1). The rest of design features, usability, safety and effectiveness are same.

- 8. Summary of Non-Clinical Data
CX50N comply with the following international and FDA-recognized consensus standards:

| 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 CX50N 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.

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### 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 IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests.

The results of these tests demonstrate that CX50N 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.