MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK

K083332 · Nec Display Solutions , Ltd. · LLZ · Jan 9, 2009 · Radiology

Device Facts

• Record ID: K083332
• Device Name: MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
• Applicant: Nec Display Solutions , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The L218TK 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 L218TK cannot be used for a life-support system. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Device Story

The L218TK is a 21.3-inch color LCD monitor providing 2-megapixel (1600x1200) resolution for medical imaging. It features adjustable gamma grayscale for diagnostic precision in CT, MRI, HIS, and PACS environments. Operated by trained physicians in clinical settings, the device displays digital images processed by NEC-approved display cards. It does not contact patients or control life-sustaining equipment. The monitor serves as a visual interface for diagnostic review, aiding physicians in clinical decision-making by providing high-resolution image visualization.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

21.3" Color LCD monitor; 2MP (1600x1200) resolution; adjustable gamma grayscale; requires NEC-approved display cards; designed for interconnection with IEC60601-1 certified equipment.

Indications for Use

Indicated for trained physicians to display and view digital diagnostic images (CT, MRI, HIS, PACS). Not for life-support systems. Must be used with NEC-approved display cards and IEC60601-1 certified equipment.

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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1083332

### JAN - 9 2009

# 510(K) Summary of Safety and Effectiveness

As required by 807.92

#### 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]

#### 2. COMPANY REISTRATION NUMBER

3003623028

#### DATE SUMMARY PREPARED 3.

24 October 2008

#### DEVICE NAME 4.

| Trade Name: | MD21M 21.3" Diagnostic Imaging LCD monitor |
|----------------------|----------------------------------------------------------------|
| Model Number: | L218TK |
| 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 5.

Vİ

Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) 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 L218TK 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 L218TK cannot be used for a life-support system.

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

#### 7. CONCLUSION

vi

2MP Medical Color Display, L218TK has the same intended use as the predicate device MDC2130-2HC, 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 MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

JAN - 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NEC Display Solution Ltd. % Mr. Angus Hsu Prodigy Technology Consultant Co., Ltd. Safety Certification Service 1F, No. 181, Sec.2, Wunhua 1st Rd., Linkou Township Taipei 244 TAIWAN CHINA

Re: K083332

Trade/Device Name: Medical Display, L218TK Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 12, 2008 Received: November 12, 2008

### Dear Mr. Hsu:

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 ffor 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 concerning your device in the Federal Register.

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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 (OS) 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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Laura B. Morris

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

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# Indications for Use

510(k) Number (if known):

Device Niame: Medical Display, L218TK

Indications For USe: The L218TK 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.

TheL218TK cannot be used for a life-support system.

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

Prescription Use V (Part 21 CFR 801 Subpart D)

vii

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)

Stephan Remmler

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