MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ

K090218 · Nec Display Solutions , Ltd. · LLZ · Apr 15, 2009 · Radiology

Device Facts

• Record ID: K090218
• Device Name: MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
• Applicant: Nec Display Solutions , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The L218TJ color display is intended to be used for displaying of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards. The L218TJ cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Device Story

The L218TJ is a 21.3-inch color LCD monitor providing 3-megapixel (2048x1536) resolution for medical imaging. It features adjustable gamma grayscale settings to support diagnostic review of CT, MRI, HIS, and PACS images. The device is intended for use by trained physicians in hospital environments. It requires connection to NEC-approved display cards and must be interconnected exclusively with IEC60601-1 certified equipment. The monitor serves as a visual interface for clinical decision-making by displaying digital diagnostic data, aiding physicians in interpreting medical images.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including mechanical, electrical, and radiation safety evaluations, and comparison of performance characteristics against the predicate device.

Technological Characteristics

21.3" Color LCD monitor; 3MP (2048x1536) resolution; adjustable gamma grayscale; requires NEC-approved display cards; designed for interconnection with IEC60601-1 certified equipment; complies with EN60601-1-2 and UL60601-1 safety standards.

Indications for Use

Indicated for displaying and viewing digital diagnostic images by trained physicians in clinical settings. Contraindicated for life-support systems and 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

• MDC2130-2HC 21.3" 2MP Color LCD Monitor (K063579)

Submission Summary (Full Text)

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K090218
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# 510(K) Summary of Safety and Effectiveness

As required by 807.92

APR ] 5 2009

#### DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

Mr. Shuichi Kino Manager NEC Display Solutions Ltd. 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan Ph: [phone] Fax: [phone]

### COMPANY REISTRATION NUMBER 2. 3003623028

#### DATE SUMMARY PREPARED 3.

15 December 2008

#### 4. DEVICE NAME

| Trade Name: | MD213 MC 21.3" Diagnostic Imaging LCD monitor |
|----------------------|----------------------------------------------------------------|
| Model Name: | L218TJ |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |

#### 4. PREDICATE DEVICE

MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579).

#### DEVICE DESCRIPTION ડ.

V

Medical Display, L218TJ is a 21.3" Color 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.

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#### DEVICE OF INTENDRD USE 6.

The L218TJ color display is intended to be used for displaying of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.

The L218TJ cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

#### CONCLUSION 7.

V

These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NEC Display Solutions, Ltd. c/o Mr. Morten Simon Christensen Assistant Manager, Program Reviewer UL Health Sciences Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230

APR 1 5 2009

Re: K090218

Trade/Device Name: Medical Display, L218TJ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2009 Received: April 1, 2009

Dear Mr. Christensen:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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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.

(Gastroenterology/Renal/Urology) 21 CFR 876.xxx [phone] 21 CFR 884.xxx (Obstetrics/Gynecology) [phone] (Radiology) [phone] 21 CFR 892.xxx [phone] Other

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kogo218

## Indications for Use

510(k) Number (if known):

K090218

Device Name: Medical Display, L218TJ

Indications For Use. The L218TJ Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.

The L218TJ cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

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)

Huler Lemen

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

1630

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