WIDE 1MP LCD MONITOR SYSTEM

K042634 · Wide Corporation · LLZ · Oct 8, 2004 · Radiology

Device Facts

• Record ID: K042634
• Device Name: WIDE 1MP LCD MONITOR SYSTEM
• Applicant: Wide Corporation
• Product Code: LLZ · Radiology
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

WIDE 1MP LCD Monitor System™ by WIDE Corporation is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. WIDE 1MP LCD Monitor System™ is not indicated for use with Mammographic images.

Device Story

The WIDE 1MP LCD Monitor System is a high-resolution flat panel LCD monitor and graphic control board designed for displaying digital medical images. The controller board is installed into a PACS workstation computer. The system is operated by trained medical practitioners in a clinical environment to review and analyze grayscale medical images. The device does not contact the patient or control life-sustaining equipment. It serves as a visualization tool, allowing clinicians to interpret images for diagnostic or review purposes, thereby supporting clinical decision-making.

Clinical Evidence

Bench testing only. Hazard analysis performed; potential hazards classified as Minor. Compliance with safety/immunity standards including UL2601-1/EN60601-1/IEC601-1, FCC Class B, CE, VCCI, and UL 950.

Technological Characteristics

Flat panel LCD monitor system; high-resolution graphic control board; connects to PACS workstation. Standards: UL2601-1/EN60601-1/IEC601-1, FCC Class B, CE, VCCI, UL 950, cUL2601-1. Non-patient contacting. No automated diagnostic algorithms.

Indications for Use

Indicated for display and review of digital medical images by trained medical practitioners. Not indicated for use with mammographic images.

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 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023340)

Submission Summary (Full Text)

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K042634

Image /page/0/Picture/1 description: The image shows the word "WIDE" in large, bold letters. Below the word "WIDE" is the phrase "More Innovation Display Engineering". The text is black and white and appears to be a logo or brand name.

## OCT 8 - 2004

### 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: August 23, 2004

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 1MP LCD Monitor System™ Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing LLZ Name:

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

| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|----------------------------|-------------------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K023340 |
| Device Name | CORNIS 1MP 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 1MP LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying digital 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.

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

The WIDE 1MP LCD Monitor System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical

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Image /page/1/Picture/0 description: The image shows the word "WIDE" in large, bold letters. Below the word "WIDE" is the phrase "World Innovation Display Engineering". The text is white against a black background. The image appears to be a logo or a sign.

practitioners. WIDE 1MP LCD Monitor System™ is not indicated for use with Mammographic images.

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 1MP LCD Monitor System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The WIDE 1MP LCD Monitor System™ 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

# OCT 8 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042634 Trade/Device Name: WIDE 1MP LCD Monitor System™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 20, 2004 Received: September 27, 2004

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 may 20, 1910, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. rary, a fash 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) I his icitel witi anow you to oghi manieing of substantial equivalence of your device to a legally premarket nothleation: "The PDA maning of battamine of 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 If you desire spective advice for your derroom. In the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entired, comation on your responsibilities under the Act from the 001:37). Tou may ootain ourers, International and Consumer Assistance at its toll-free number (800) DVNSlott of offan Manatactarers in Internet address http://www.fda.gov/cdrb/dsmadsmamain.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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Page 1 of -1

510(k) Number: 《04263年

Device Name: WIDE 1MP LCD Monitor System™

Indications for Use:

WIDE 1MP LCD Monitor System™ by WIDE Corporation is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners.

WIDE 1MP LCD Monitor System™ is not indicated for use with Mammographic images.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number