MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM

K073292 · Heeyoung Co., Ltd. · LLZ · Jan 18, 2008 · Radiology

Device Facts

• Record ID: K073292
• Device Name: MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
• Applicant: Heeyoung Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. This device must not be used for primary image diagnosis in mammography

Device Story

MM/MMA/Color Series Digital Flat Panel Display System is a high-resolution LCD monitor and graphic control board; connects to PACS workstations. Operates as a display interface for grayscale and color medical images. Used in clinical settings by physicians or trained medical practitioners. Device receives digital image data from PACS; transforms data for visual output on high-resolution screen. Healthcare providers use displayed images for review and analysis to support clinical decision-making. Does not contact patient; does not control life-sustaining equipment.

Clinical Evidence

No clinical data. Bench testing only, including hazard analysis and compliance with safety/immunity standards (UL2601-1/EN60601-1, IEC601-1, FCC Class B, CE, VCCI, UL 950).

Technological Characteristics

High-resolution LCD monitor and graphic control board. Connectivity: PACS workstation interface. Standards: UL2601-1/EN60601-1, IEC601-1, FCC Class B, CE, VCCI, UL 950, cUL2601-1. Software-based image display system. No patient contact. Non-life-sustaining.

Indications for Use

Indicated for trained medical practitioners to display and view digital medical images for review and analysis. Contraindicated for primary image diagnosis in mammography.

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

• CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM (K013922)
• WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A (K032174)

Submission Summary (Full Text)

{0}------------------------------------------------

K073292
pg. 1 of 2

126 1 3 3008

# 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:

November 10, 2007

Submitter's Information: 21 CFR 807.92(a)(1) Mr. K.S. Yun General Manager HeeYoung Co., Ltd. 048-8, Shin-Dong, Danwon-gu, Ansan City, Kyunggi-do 425-839 Korea Email: [e-mail]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: MM/MMA/Color Series Digital Flat Panel Display System Picture Archiving Communications System Common Name: Device Classification: 892.2050 - LLZ Name: System, Image Processing

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

| 510(k) Number | K013922 | K032174 |
|--------------------------------------|----------------------------------------------------|--------------------------------------------------|
| Device Classification Name | system, image<br>processing, radiological | system, image<br>processing, radiological |
| Device Name | CORONIS 3MP<br>MEDICL FLAT PANEL<br>DISPLAY SYSTEM | WIDE 3MP GRAYSCALE<br>TFT LCD MONITOR<br>IF2103A |
| Applicant | BARCO NV | WIDE Corporation |
| Regulation Number | 892.2050 | 892.2050 |
| Classification Product Code | LLZ | LLZ |
| Decision Date | 01/28/2002 | 07/24/2003 |
| Decision | substantially equivalent<br>(SE) | substantially equivalent<br>(SE) |
| Classification Advisory<br>Committee | Radiology | Radiology |

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

The MM/MMA/Color Series Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying 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 and color image

l

{1}------------------------------------------------

K073292
PG.2 of 2

# 510(k) Summary of Safety and Effectiveness

display. The 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 MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. This device must not be used for primary image diagnosis in mammography

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 displaved.

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

The 510(k) Pre-Market Notification for the MM/MMA/Color Series Digital Flat Panel Display System™ contains adequate information and data to enable FDA -CDRH to determine substantial equivalence to the predicate device.

The WIDE MM/MMA/Color Series Digital Flat Panel Display System™ will be manufactured by HeeYoung Co., Ltd. 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.

{2}------------------------------------------------

### 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 graphic of three angled lines that resemble a human figure. The graphic is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2008

HeeYoung Co., Ltd. % Mr. Carl Thomas Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K073292

Trade/Device Name: MM/MMA/Color Series Digital Flat Panel Display System™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 11, 2007 Received: November 23, 2007

Dear Mr. Thomas:

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 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 conceming your device in the Federal Register.

{3}------------------------------------------------

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/cdrb/industry/support/index.html.

Sincerely yours.

Nancy Brogdon

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

Enclosure

{4}------------------------------------------------

Page 1 of -1

(Indications for Use Form)

510(k) Number:

K073292

Device Name: MMMMA/Color Series Digital Flat Panel Display System™

Indications for Use:

The MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

This device must not be used for primary image diagnosis in mammography

OR

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

hry h Whx

Division of Reproductive. Abdomina Radiological Devices 510(k) Number