WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A

K032174 · Wide Corporation · LLZ · Jul 24, 2003 · Radiology

Device Facts

• Record ID: K032174
• Device Name: WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
• Applicant: Wide Corporation
• Product Code: LLZ · Radiology
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The WIDE 3MP grayscale TFT LCD monitor IF2103A ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

Device Story

The WIDE 3MP grayscale TFT LCD monitor IF2103A is a high-resolution flat panel LCD system designed for displaying digital medical images. The system comprises an LCD monitor and a high-resolution graphic control board installed into a PACS workstation. It is used in clinical environments by trained medical practitioners to review and analyze medical images. The device functions as a display interface; it does not perform automated image processing or diagnostic analysis. The healthcare provider uses the displayed images to support clinical decision-making. The device benefits patients by providing a high-resolution platform for accurate visualization of diagnostic medical imagery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

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

Indications for Use

Indicated for trained medical practitioners to display and view digital 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 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K013922)

Submission Summary (Full Text)

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JUL 2 4 2003

032174

Image /page/0/Picture/2 description: The image shows the word "WIDE" in white letters on a black background. Below the word "WIDE" is some smaller text that is difficult to read. The text is also in white. The image is a logo or advertisement for something.

## 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: June 7, 2002

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) WIDE 3MP grayscale TFT LCD monitor IF2103A TM Trade Name: 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 | K013922 |
| Device Name | CORNIS 3MP MEDICAL FLAT PANEL DISPLAY<br>SYSTEM |
| Applicant | BARCO NV<br>P.O. BOX 12038<br>LA JOLLA, CA 92039 2038 |
| Product Code | LLZ |
| Decision Date | 12/23/2002 |

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

The WIDE 3MP grayscale TFT LCD monitor IF2103A™is a flat panel hiresolution 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 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 word is centered and takes up most of the frame. Below the word "WIDE" is some smaller text that is difficult to read due to the image quality.

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

The WIDE 3MP grayscale TFT LCD monitor IF2103A ™ is intended to be used in displaying and viewing digital 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 WIDE 3MP grayscale TFT LCD monitor IF2103A ™ contains adequate information and data to enable FDA -CDRH to determine substantial equivalence to the predicate device.

The WIDE 3MP grayscale TFT LCD monitor IF2103A ™ will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards, i.e. Safety / Immunity 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

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

Re: K032174

Trade/Device Name: WIDE 3MP grayscale TFT LCD monitor IF2103A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: June 30, 2003 Received: July 16, 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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## (Indications for Use Form)

510(k) Number: K632174

Device Name: WIDE 3MP grayscale TFT LCD monitor IF2103A ™

Indications for Use:

The WIDE 3MP grayscale TFT LCD monitor IF2103A™is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

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

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NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David R. Lyman