WIDE 5MP (MAMMO) LCD MONITOR SYSTEM

K052312 · Wide Corporation · LLZ · Oct 7, 2005 · Radiology

Device Facts

• Record ID: K052312
• Device Name: WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
• Applicant: Wide Corporation
• Product Code: LLZ · Radiology
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The 5MP (Mammo) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Device Story

The 5MP (Mammo) LCD Monitor System is a high-resolution flat panel LCD monitor and graphic control board. The controller board is installed into a PACS workstation computer. The system receives digital image data from the PACS workstation and displays grayscale medical images for review and analysis by trained medical practitioners. It is used in clinical settings where medical imaging is interpreted. The device does not contact the patient and does not control life-sustaining equipment. It provides high-resolution visualization to assist physicians in interpreting mammography and other medical images, facilitating clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only, including hazard analysis and compliance with safety and EMC standards (UL2601-1, EN60601-1, IEC601-1-2, FCC Class B).

Technological Characteristics

High-resolution LCD monitor and graphic control board. Standards: UL2601-1/EN60601-1 (Safety), IEC601-1-2 (EMC), FCC Class B, CE, VCCI, UL 950. Connectivity: PACS workstation integration. Non-patient contacting.

Indications for Use

Indicated for trained medical practitioners to display and view medical digital images, specifically for digital mammography 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

• CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K041508)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "WIDE" in large, bold, white letters against a black background. Above the word "WIDE" is the number "2052312" written in black ink. Below the word "WIDE" is some text that is too small to read.

## 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 22, 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 Phone: [phone] 297-0521 Fax:

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) 5MP (Mammo) LCD Monitor System™ Trade Name: Common Name: Picture Archiving Communications System 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 | K041508 |
| Device Name | CORNIS 5MP MEDICAL FLAT PANEL DISPLAY<br>SYSTEM |
| Applicant | BARCO NV |
| Product Code | LLZ |
| Decision Date | 8/27/2004 |

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

The 5MP (Mammo) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical and mammography 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 rectangular background. Below the rectangle, there is some smaller text that is difficult to read due to its size and the image quality. The overall design appears to be a logo or branding element, with the focus on the prominent "WIDE" text.

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

The 5MP (Mammo) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

#### 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 (Mammo) LCD Monitor System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The 5MP (Mammo) LCD Monitor System™ will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards: Safety / lmmunity UL2601-1/EN60601-1 210 Edition, Medical Electrical Equipment, / IEC601-1-2 200 Edition EMC Requirements, 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WIDE Corporation % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210 Re: K052312 Trade/Device Name: 5MP (Mammo) LCD Monitor System™ by WIDE Corporation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2005 Received: August 26, 2005

Dear Mr. Alletto:

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 (Premarket Approval), it may be subject to such 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 docs 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 letter wit anow your o organ interes of your device of your device to a legally marketed predication: " Price PDF milling star 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 specific active for your cerrethe 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 on your responsibilities under the Act from the 807.77). It ou may obtain only general missistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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)

K052312 510(k) Number:

Device Name:

5MP (Mammo) LCD Monitor System™ by WIDE Corporation

Indications for Use:

The 5MP (Mammo) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

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 R. Syrom

and Ra 510k) N