21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A

K070370 · Totoku Electric Co., Ltd. · LLZ · Mar 9, 2007 · Radiology

Device Facts

• Record ID: K070370
• Device Name: 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3-inch (54cm) Monochrome LCD Monitor MDL2122A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Device Story

The MDL2122A is a 21.3-inch monochrome LCD monitor designed for clinical diagnostic imaging. It accepts both digital and analog video signals to provide UXGA (1600 x 1200) resolution in either landscape or portrait orientation. Used by trained medical practitioners in clinical settings, the device serves as a visual interface for reviewing medical images to support clinical decision-making. It does not perform automated image analysis or processing; it functions as a display peripheral for medical imaging systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

21.3-inch monochrome LCD monitor; UXGA (1600 x 1200) resolution; supports digital and analog video signals; landscape and portrait display modes.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for diagnostic purposes. 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

• MDL2121A (K063198)

Submission Summary (Full Text)

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## TOTOKU

:

KOP370

## 510(k) SUMMARY

| Submitter Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan | MAR 09 2007 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Mikio Hasegawa, General Manager<br>Email: [e-mail]<br>Tel:[phone]<br>Fax:[phone] | |
| Date Prepared: | February 6, 2007 | |
| Device Name: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A | |
| Common Name: | MDL2122A, 2M Monitor/Display | |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | MDL2121A (K063198) | |
| Device Description: | MDL2122A is a 21.3-inch Monochrome LCD Monitor that supports<br>both digital & analog video signals, and provides UXGA (1600 x<br>1200) resolution for both landscape and portrait display. | |
| Intended Use: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A is to be<br>used in displaying and viewing medical images for diagnosis by<br>trained medical practitioners. It is not meant to be used for digital<br>mammography. | |
| Substantial Equivalence: | MDL2122A shares the same characteristics with our predicate<br>device MDL2121A (K063198) except for the analog video signal. | |

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health and Human Services (HHS), which is a stylized human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The logo is simple and recognizable, representing the HHS and its mission.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN

MAR 0 9 2007

Re: K070370

Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2007 Received: February 8, 2007

Dear Mr. Hasegawa:

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/1/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal has a dotted border.

Protecting and Promoting Public Health

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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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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: Not Known

Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A Indications for Use:

21.3-inch (54cm) Monochrome LCD Monitor MDL2122A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

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