5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION

K031929 · Wide Corporation · LLZ · Jul 8, 2003 · Radiology

Device Facts

• Record ID: K031929
• Device Name: 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
• Applicant: Wide Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The 5MP TFT LCD Monitor System IF2105A ™ is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Device Story

The 5MP TFT LCD Monitor System IF2105A is a high-resolution flat panel LCD monitor system designed for medical imaging. It consists of an LCD monitor and a high-resolution graphic control board installed into a PACS workstation. The system receives digital image data from the PACS workstation and displays grayscale medical images for review and analysis by trained medical practitioners in a clinical setting. The device does not contact the patient and does not control life-sustaining equipment. It serves as a visualization tool, allowing clinicians to interpret diagnostic images to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were verified through compliance with voluntary standards including UL2601-1, EN60601-1, IEC601-1, FCC Class B, and CE marking. Hazard analysis classified potential risks as Minor.

Technological Characteristics

High-resolution TFT LCD monitor and graphic control board. Standards: UL2601-1/EN60601-1/IEC601-1, FCC Class B, CE, VCCI, UL 950, cUL2601-1. Connectivity: Integrates with PACS workstation via graphic control board. Non-patient contacting. No life-sustaining function.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for review and analysis.

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

• CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023341)

Submission Summary (Full Text)

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Ko3 1929

Image /page/0/Picture/1 description: The image shows the word "WIDE" in large, bold letters. The word is set against a black background, and there is some text below it that is difficult to read due to the image quality. The text appears to be a tagline or description associated with the word "WIDE."

# JUL 0 8 2003

### 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: May 22, 2003

Submitter's Information: 21 CFR 807.92(a)(1) WIDE Corporation Mr. YS Lim, President & CEO 576-5 Miwon-Ri, Miwon-Myun, Cheongwon-Gun Chung, Korea 363-874

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) 5MP TFT LCD Monitor System IF2105A ™ by WIDE Trade Name: Corporation Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:

Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|----------------------------|-------------------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K023341 |
| Device Name | CORNIS 5MP MEDICAL FLAT PANEL DISPLAY<br>SYSTEM |
| Applicant | BARCO NV<br>P.O. BOX 12038<br>LA JOLLA, CA 92039 2038 |
| Product Code | LLZ |
| Date Received | 10/07/2002 |
| Decision Date | 12/23/2002 |

#### Device Description: 21 CFR 807 92(a)(4)

The 5MP TFT LCD Monitor System IF2105A™ is a flat panel hi-resolution LCD monitor system for displaying medical images. The system consists of a state-ofthe-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 used to display PACS medical images.

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Image /page/1/Picture/0 description: The image shows the word "WIDE" in large, bold, white letters against a black background. The letters are slightly distressed, giving them a textured appearance. Below the word "WIDE", there is some smaller text that is difficult to read due to its size and the image quality. The overall impression is of a logo or branding element with a simple, impactful design.

Indications for Use: 21 CFR 807 92(a)(5)

The 5MP TFT LCD Monitor System IF2105A ™ is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device is an image display system consisting 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.

#### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the 5MP TFT LCD Monitor System IF2105A ™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The 5MP TFT LCD Monitor System IF2105A ™ will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards, i.e. Safety / lmmunity UL2601-1/EN60601-1 / IEC601-1, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B digital device, pursuant to Part 15.

The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

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Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are depicted in a flowing, abstract manner, creating a sense of movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 0 8 2003

Re: K031929

WIDE Corporation % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Trade/Device Name: 5MP TFT Monitor System IF2105A™ by WIDE Corporation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systern Regulatory Class: II Product Code: 90 LLZ

Dated: June 12, 2003 Received: June 23, 2003

Dear Mr. Devine:

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.

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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko 3 192 9 510(k) Number:

Device Name:

5MP TFT LCD Monitor System IF2105A™ by WIDE Corporation

Indications for Use:

The 5MP TFT LCD Monitor System IF2105A ™ is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

✓

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David A. Syverson

510(k)