MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG

K083907 · Nec Display Solutions , Ltd. · LLZ · Jan 13, 2009 · Radiology

Device Facts

• Record ID: K083907
• Device Name: MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
• Applicant: Nec Display Solutions , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The L217TG 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 L217TG 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

L217TG is a 21.3-inch color LCD monitor providing 2-megapixel (1600x1200) resolution; features adjustable gamma grayscale for diagnostic precision. Used in hospitals/clinics for viewing CT, MRI, HIS, and PACS images. Operated by trained physicians. Requires connection to NEC-approved display cards and IEC60601-1 certified equipment. Device transforms digital signals into visual diagnostic images to assist clinical decision-making; provides high-resolution visualization for medical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparison of design, performance, and safety standards (electrical, mechanical, and radiation safety) against the predicate device.

Technological Characteristics

21.3" Color LCD monitor; 2MP (1600x1200) resolution; adjustable gamma grayscale. Requires NEC-approved display cards. Complies with IEC60601-1, UL60601-1, and EN60601-1-2 safety standards. Standalone display unit.

Indications for Use

Indicated for the display and viewing of digital diagnostic images by trained physicians in clinical settings (CT, MRI, HIS, PACS). 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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K0r3907

# 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]

### COMPANY REISTRATION NUMBER 2.

3003623028

#### DATE SUMMARY PREPARED 3.

24 October 2008

#### DEVICE NAME 4.

| Trade Name: | MD212 MC 21.3" Diagnostic Imaging LCD monitor |
|----------------------|----------------------------------------------------------------|
| Model Name: | L217TG |
| 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.

Medical Display, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I 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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#### б. INTENDRD USE OF DEVICE

The L217TG 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 L217TG 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.

#### 7. CONCLUSION

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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AN 1 3 2009

NEC Display Solutions Ltd. % Mr. Marc M. Mouser Manager/FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607

Re: K083907

Trade/Device Name: Medical Display, L217TG Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2008 Received: December 30, 2008

### Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device for use at tod in the 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, its ing 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 . In audi

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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 electionic 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 CDRF 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.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

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## Indications for Use

## 510(k) Number (if known):

Device Name: Medical Display, L217TG

Indications For USe: The L217TG 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 L217TG 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 | X |
|-----------------------------|---|
| (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)

Tommy McWhirter

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 083907 510(k) Number

iii .