3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC

K063266 · Chi Lin Technology Co., Ltd. · LLZ · Nov 9, 2006 · Radiology

Device Facts

• Record ID: K063266
• Device Name: 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
• Applicant: Chi Lin Technology Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Medical Display, MDM2130-3NC 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

Medical Display MDM2130-3NC is a 21.3-inch monochrome LCD monitor; provides 3-megapixel (2048x1536) resolution; features adjustable gamma gray scale. Used in clinical settings (CT, MRI, HIS, PACS) by trained medical practitioners for image review and diagnostic analysis. Device does not contact patients; does not control life-sustaining equipment. Output allows clinicians to visualize diagnostic images to support clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; 3-megapixel (2048x1536) resolution; adjustable gamma gray scale. Standalone display device.

Indications for Use

Indicated for trained medical practitioners to display, review, and analyze medical images for diagnostic purposes in CT, MRI, HIS, and PACS environments. Not indicated for digital 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

• Medical Display - MDM1900-1NR 19" Monochrome LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061303)

Submission Summary (Full Text)

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K063266

# 510(K) Summary of Safety and Effectiveness

As required by 807.92

NOV - 9 2006

## DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

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

28 June 2006

#### 3. DEVICE NAME

Trade Name: Medical Display, MDM2130-3NC Common Name: Monochrome LCD Monitor, Monochrome Diagnostic Display, etc.

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

#### 4. PREDICATE DEVICE

Medical Display - MDM1900-1NR 19" Monochrome LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061303).

#### 5. DEVICE DESCRIPTION

Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale 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, MDM2130-3NC 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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## CONCLUSION 7.

Medical Display, MDM2130-3NC has the same intended use as the predicate device MDM1900-1NR, 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 MDM1900-1NR by CHILIN TECHNOLOGY CO., LTD. (K061303).

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Chi Lin Technology Co., LTD. % Mr. Marc M. Mouser Senior Project Engineer, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

NOV - 9 2006

Re: K063266

Trade/Device Name: Medical Display, MDM2130-3NC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 27, 2006 Received: October 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.

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ad Promoting Public 9

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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/cdrh/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): K063264

Device Name: Medical Display, MDM2130-3NC

Indications For User 3MP Mcdical Monochrome Reference Display, MDM2130-3NC 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.

V 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)

Nancy C Broadon

(Division Sign-Off) Division of Reproducti and Radiological Device 510(k) Numbe