2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC

K063579 · Chi Lin Technology Co., Ltd. · LLZ · Dec 14, 2006 · Radiology

Device Facts

• Record ID: K063579
• Device Name: 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
• Applicant: Chi Lin Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Medical Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Device Story

21.3" color LCD monitor; 2-megapixel (1600x1200) resolution; displays medical images for review/analysis by trained practitioners in CT, MRI, HIS, and PACS environments. User-definable DICOM GSDF Gamma settings (1.8, 2.0, 2.2) for diagnostic precision. Device does not contact patient; does not control life-sustaining equipment. Not for digital mammography.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

21.3" color LCD monitor; 2MP (1600x1200) resolution; supports DICOM GSDF Gamma settings (1.8, 2.0, 2.2).

Indications for Use

Indicated for trained medical practitioners to review and analyze medical images from CT, MRI, HIS, and PACS. Not for use in digital mammography systems.

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

• Medical Display - MDC1900-1LG 19" color LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061305)

Submission Summary (Full Text)

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510(K) Summary of Safety and Effectiveness

As required by 807.92

### DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

DEC / 4 2006

Phil Chen CHILIN TECHNOLOGY CO., LTD. No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 -- 4751

#### 2. DATE SUMMARY PREPARED

08 September 2006

#### 3. DEVICE NAME

Trade Name: Medical Display, MDC2130-2HC Common Name: Color LCD Monitor, Monochrome Diagnostic Display, etc.

Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)

#### 4. PREDICATE DEVICE

Medical Display - MDC1900-1LG 19" color LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061305).

#### 5. DEVICE DESCRIPTION

Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

#### 6. DEVICE OF INTEND USE

Medical Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system

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#### 7. CONCLUSION

:

Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to MDC1900-1LG by CHILIN TECHNOLOGY CO., LTD. (K061305).

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## Third Party Review Quality Assessment

Section 1 - Submission Information

ﻟﺪﻳﻨﺎ

| 510(k) No.: | K063579 |
|------------------------------------|------------------|
| Third Party Organization: | Underwriters Inc |
| Third Party's Primary Reviewer(s): | Thomas Huang |
| ODE/OIVD Division: | ODE |
| Branch/Team: | DRARD / RADB |

Section 2 - 510(k) Decision

| Third party recommendation: | SE <span style="text-decoration: overline;">✓</span> NSE ______ Other (specify): ______ |
|-----------------------------|-----------------------------------------------------------------------------------------|
| ODE/OIVD final decision: | SE <span style="text-decoration: overline;">✓</span> NSE ______ Other (specify): ______ |

Section 3 - Assessment of Third Party Review

| Review Element | | Rating (check one) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------------------|-------------------|--|
| | Adequate | Minor<br>Issue(s) | Major<br>Issue(s) | |
| a. Determination of device eligibility for third party review | ✓ | | | |
| b. Extent of pre-submission consultation with ODE/OIVD division | | | | |
| c. Organization and format of review documentation | | | | |
| d. Determination of 510(k) administrative completeness (screening<br>review) | | | | |
| e. Summary of device characteristics, intended use, and performance<br>(including accessories, if applicable) and reason for 510(k) submission | ✓ | | | |
| f. Comparison to legally marketed devices-identification and analysis of<br>key similarities and differences | | | | |
| g. Rationale for conclusions and recommendation | ✓ | ✓ | | |
| h. Use of guidance documents and standards | | | | |
| i. Resolution of 510(k) deficiencies and FDA requests for additional<br>information | | | | |
| j. Scope of reviewer expertise and use of consulting reviewers | | | | |
| k. Other (specify): | | | | |

Comments (explanation of ratings/issues):

Section 4 - ODE/OIVD Assessur Intornation

Assessed by: Khan

Date: 12-5-06 Tel No: 276

Routing) Division Chp completed assessment (this page only) (o inside from cover of >(0) DMC Town addition page only to Rechen, POS/ODF, Rin 1209, Corp. Blvd. (HF/ 2011

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC 1 4 2006

CHI LIN Technology Co., Ltd. c/o Mr. Marc M. Mouser Sr. Project Engineer, Program Reviewer Underwriter Laboratories, Inc. 2600 N. W. Lake Road CAMAS WA 98607-8542

Re: K063579

Trade/Device Name: Medical Display, MDC2130-2HC Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2006 Received: November 30, 2006

Dear Mr. Mouser:

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.

Image /page/3/Picture/10 description: The image shows a circular logo for the FDA Centennial 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. Three stars are placed below the word "Centennial". The logo is surrounded by text that follows the circular shape.

ng and Promoting Public St

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Page 2 -

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrlv/industry/support/index.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

510(k) Number (if known):

Device Name: Medical Display, MDC2130-2HC

Indications For Use: 2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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