CX30N (CX30PQX)

K210493 · Wide Corporation · PGY · Apr 14, 2021 · Radiology

Device Facts

• Record ID: K210493
• Device Name: CX30N (CX30PQX)
• Applicant: Wide Corporation
• Product Code: PGY · Radiology
• Decision Date: Apr 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CX30N(CX30PQX) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

Device Story

The CX30N(CX30PQX) is a 3MP color LCD medical monitor system used by trained medical practitioners in clinical settings for the display, review, and analysis of digital medical images (excluding mammography). The device receives digital image data from PACS or radiology systems via DVI-D or DisplayPort interfaces. It utilizes a dual domain IPS TFT color LCD panel with LED backlighting to render images. The system includes the EzCal v.2 software solution, which allows users to calibrate the display output to meet DICOM Part 14 GSDF and other industry standards. The monitor features integrated sensors (backlight, IQ, and ambient light) to maintain image quality and luminance uniformity. By providing high-resolution, calibrated visualization, the device assists clinicians in interpreting medical images, thereby supporting diagnostic decision-making.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against 'Display Devices for Diagnostic Radiology' FDA guidance, including tests for pixel defects, luminance, resolution, noise, veiling glare, and color/gray tracking. Safety validated per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Dual domain IPS TFT color LCD panel; 3MP (1536 x 2048) resolution; 1000 cd/m² max luminance; LED backlighting; 10-bit/8-bit input support; DVI-D and DisplayPort connectivity. Includes EzCal v.2 calibration software. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for trained medical practitioners to display, review, and analyze digital medical images. Not intended for mammography.

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

• RadiForce RX350 (K153354)

Submission Summary (Full Text)

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April 14, 2021

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wide Corporation % Mr. YeoJin Yun RA Manager 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-Si. Gyeonggi-Do 18469 REPUBLIC OF KOREA

Re: K210493

Trade/Device Name: CX30N (CX30PQX) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2021 Received: February 19, 2021

Dear Mr. Yun:

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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K210493

Device Name CX30N(CX30PQX)

#### Indications for Use (Describe)

The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 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)]

03/16/2021

#### 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 |

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

Model Name: CX30N(CX30PQX) TFT LCD Medical Monitor System Common Name: Classification Name: Display, Diagnostic Radiology 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: | K153354 |
|----------------------|----------------------------------------|
| Applicant: | EIZO CORPORATION |
| Model Name: | 3MP Color LCD Monitor, RadiForce RX350 |
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |

K210493

510(k) Summary 1/4

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

CX30N(CX30PQX) 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.

CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

CX30N is basic model and CX30PQX is identical to CX30N, except model name.

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

CX30N(CX30PQX) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

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

The device is an image display system which consists of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.

| Attributes | Predicate Device | Subject Device | Discussion<br>of<br>Differences |
|----------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------|
| Product | RadiForce RX340 | CX30N(CX30PQX) | - |
| Screen<br>technology | IPS TFT Color LCD<br>Panel | Dual domain IPS TFT<br>Color LCD Panel | - |
| Viewing<br>angle (H, V) | H: 170°, V: 170° | H: 178°, V: 178° | Provided by the panel<br>manufacturers. |
| Active screen<br>size | 323.7 mm x 431.6 mm | 324.86 mm x 433.15 mm | Provided by the panel<br>manufacturers. |
| Resolution | 3MP (1,536 x 2,048) | 3MP (1,536 x 2,048) | - |
| Aspect ratio | 3 : 4 | 3:4 | - |
| Pixel pitch | 0.21075 mm x 0.21075<br>mm | 0.2115 mm x 0.2115<br>mm | Provided by the panel<br>manufacturers. |
| Maximum<br>luminance | 1,000 cd/m² | 1,000 cd/m² | - |
| DICOM<br>calibrated<br>luminance | 400 cd/m² | 450 cd/m² | Differences by<br>manufacturers. |
| Contrast ratio | 1400 : 1 | 1500 : 1 | Provided by the panel<br>manufacturers. |
| Backlighting | LED | LED | - |
| Display<br>Colors | From a palette of 68<br>billion colors:<br>- 10-bit input<br>(DisplayPort): 1.07 | From a palette of 68<br>billion colors:<br>- 10-bit input<br>(DisplayPort): 1.07 | - |

### 8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

510(k) Summary 2/4

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| | billion colors<br>(maximum)<br>- 8-bit input: 16.77<br>million colors | billion colors<br>(maximum)<br>- 8-bit input: 16.77<br>million colors | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Luminance<br>non-uniformity<br>compensation | Digital Uniformity<br>Equalizer | Luminance<br>Uniformity<br>Control | It is only a difference in<br>terms of each<br>manufacturer, but the<br>functions are similar. |
| Input video<br>signals | DVI-D (dual link) x 1,<br>DisplayPort x 1 | DVI-D (dual link) x 1,<br>DisplayPort x 1 | - |
| Scanning<br>Frequency<br>(H, V) | 31 - 127 kHz, 29 - 61<br>Hz<br>(VGA Text: 69 - 71 Hz)<br>Frame synchronous<br>mode: 29.5 - 30.5 Hz,<br>59 - 61 Hz | 96KHz, 60Hz | Differences by<br>manufacturers. |
| Power<br>Requirements | AC 100 - 120 V,<br>200 - 240 V: 50 / 60 Hz | AC 100~240 V: 50 / 60<br>Hz<br>DC +24V, 2.4A | Differences by<br>manufacturers. |
| Power<br>Consumption<br>/ Save Mode | 125 W / Less than 3 W | 75 W / Less than 2 W | Differences by<br>manufacturers. |
| Power<br>Management | DVI DMPM,<br>DisplayPort 1.1a | DVI DMPM,<br>DisplayPort 1.1a | - |
| 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>Presence Sensor,<br>Integrated Front<br>Sensor,<br>Ambient Light Sensor | Backlight Sensor,<br>IQ Sensor,<br>Ambient Light Sensor | It is only a difference in<br>terms of each<br>manufacturer, but the<br>functions are similar.<br>but Integrated Front<br>Sensor is not used. |
| USB Ports /<br>Standard | 1 upstream,<br>2 downstream / Rev.<br>2.0 | 1 upstream,<br>3 downstream / Rev.<br>3.0 | Differences by<br>manufacturers. |
| Dimensions<br>w/o stand<br>(W x H x D) | 376 x 505 x 98 mm | 366 x 476 x 65.5 mm | Different housing<br>design due to the<br>different panel size |

CX30N(CX30PQX) Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.

# 9. Summary of Non-Clinical Data

CX30N(CX30PQX) 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 - |
| 510(k) Summary 3/4 | |

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# Requirements And Tests

The bench tests below were performed on the CX30N(CX30PQX) 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, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in diagonal, horizontal, and vertical directions, Temporal Performance test, Color Tracking, Gray Tracking

#### 10. Summary of Clinical Data

No clinical studies were considered necessary and performed.

## 11. Conclusion [21 CFR 807.92(b) (3)]

Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, 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 CX30N(CX30PQX) 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.