MX50N(MX50YQS)

K170781 · Wide Corporation · PGY · Apr 4, 2017 · Radiology

Device Facts

• Record ID: K170781
• Device Name: MX50N(MX50YQS)
• Applicant: Wide Corporation
• Product Code: PGY · Radiology
• Decision Date: Apr 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MX50N(MX50YQS) 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

MX50N(MX50YQS) is a high-resolution TFT LCD medical monitor system. It receives digital medical image data from a PACS workstation via a high-resolution graphic control board. The system displays grayscale images for review and analysis by trained medical practitioners in clinical settings. It is designed for digital mammography and breast tomosynthesis. The device does not contact the patient or control life-sustaining equipment; it serves as a visualization tool for diagnostic interpretation. The healthcare provider uses the displayed images to make clinical decisions. The device benefits patients by providing high-fidelity visualization of medical images for accurate diagnostic review.

Clinical Evidence

No clinical data. Bench testing only. Performance validated through tests for resolution, luminance, contrast, and noise, meeting all acceptance criteria. Safety validated via IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

21.3" TFT LCD monitor; 2560 x 2048 resolution; 0.165mm x 0.165mm pixel pitch; 1200cd/m² brightness; 1000:1 contrast ratio; 25ms response time. Inputs: DVI-I, DisplayPort. Power: 100-240 VAC, 50/60Hz. Monochrome display. Includes high-resolution graphic control board for PACS workstation integration. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for trained medical practitioners to display and view 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

• 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) (K160326)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2017

WIDE Corporation % YeoJin Yun RA Manager 12 Wongomae-Ro, Giheung-Gu Yongin-Si, Gyeonggi-Do 17086 REPUBLIC OF KOREA

Re: K170781

Trade/Device Name: MX50N(MX50YOS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 10, 2017 Received: March 17, 2017

Dear YeoJin 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170781

Device Name MX50N(MX50YQS)

#### Indications for Use (Describe)

MX50N(MX50YQS) 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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)]

03/10//2017

## 2. Submitter's Information [21 CFR 807.92(a) (1)]

| Name of Sponsor: | WIDE Corporation. |
|-----------------------|--------------------------------------------------------------------------------|
| Address: | 12 Wongomae-Ro, Giheung-Gu, Yongin-Si, Gyeonggi-Do<br>17086, 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: | MX50N(MX50YQS) |
|----------------------|--------------------------------|
| Common Name: | TFT LCD Medical Monitor System |
| 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: K160326 |
|---------------------------------------------------------------------|
| Applicant: JVC KENWOOD Corporation |
| Model Name: 5MP Monochrome LCD Monitor MS55i2<br>(ML21055, MD211G5) |
| Common Name: TFT LCD Medical Monitor System |
| Classification Name: Display, Diagnostic Radiology |
| Regulation Number: 21 CFR 892.2050 |
| Product Code: PGY |
| Device Class: 2 |

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

MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.

Subject of this new 510(k) premarket notification is an addition to the indications for use for the MX50N(MX50YQS). The device was cleared via premarket notification K160353. There is no any change of configuration/components and functionality of the subject device as compared with cleared device (K160353).

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

The MX50N(MX50YQS) 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 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.

| Parameter | Subject Device | Predicate Device |
|---------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K160326 |
| Model Name | MX50N(MX50YQS) | 5MP Monochrome LCD<br>Monitor MS55i2<br>(ML21055, MD211G5) |
| Manufacturer | WIDE Corporation. | JVC KENWOOD Corporation |
| Common Name | TFT LCD Medical Monitor System | |
| Classification Name | Display, Diagnostic Radiology | |
| Classification Panel | Radiology | |
| Classification Regulation | 21 CFR 892.2050 | |
| Product Code | PGY | |
| Device Class | Class II | |
| Intended Use | The MX50N(MX50YQS) LCD<br>Monitor System is intended to be<br>used in displaying and viewing | 5MP Monochrome LCD<br>Monitor MS55i2 (ML21055,<br>MD211G5) are intended to be |

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

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| Parameter | Subject Device | Predicate Device |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | digital medical images for review<br>and analysis by trained medical<br>practitioners. It is specifically<br>designed for digital mammography<br>applications and digital breast<br>tomosynthesis applications. | used in displaying and viewing<br>medical images for diagnosis by<br>trained medical practitioners.<br>They are to be used in digital<br>mammography PACS<br>modalities including FFDM, and<br>breast tomosynthensis. |
| Response Time<br>(Typical) | 25ms (On/Off) | 25ms (On/Off) |
| LCD Panel Size | 21.3" | 21.3" |
| Resolution | 2560 x 2048 | 2560 x 2048 |
| Pixel pitch | 0.165mm x 0.165mm | 0.165mm x 0.165mm |
| Brightness | 1200cd/m² | 1200cd/m² |
| Contrast Ratio | 1000 : 1 | 1200 : 1 |
| Input Signal | DVI-I, DisplayPort | DVI-I |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Monochrome | Monochrome |

When compared to the predicate devices (K160326), the MX50N(MX50YQS) presented in this submission has the same of the followings:

- Intended Use
- Technological characteristics
- Response Time
- LCD Panel Size
- Resolution
- Pixel pitch
- · Brightness

The two devices share the similar performance as the following:

- Contrast Ratio
There is no significant difference between the MX50N(MX50YQS) and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in intended use, technological characteristics, panel size, resolution, pixel pitch, Brightness and contrast ratio.

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#### 9. Summary of Non-Clinical Data

MX50N(MX50YQS) 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 tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards.

#### 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, fundamental scientific technology, indications for use, and safety and effectiveness. Even though the predicate device and the subject device differ in the brightness, the difference is not a critical in the effectiveness because subject device covers brightness range of predicate device.

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 tests for resolution, luminance, contrast and noise.

The results of these tests demonstrate that MX50N(MX50YQS) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical 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.