20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)

K061061 · Tokotu Electric Co., Ltd. · LLZ · Jun 7, 2006 · Radiology

Device Facts

• Record ID: K061061
• Device Name: 20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
• Applicant: Tokotu Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) 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

20.1-inch color LCD monitor; displays medical images for diagnostic review by trained medical practitioners. Accepts video input signals ranging from VGA (640x480) to UXGA (1600x1200); compliant with VESA standard display modes. Used in clinical environments; provides visual output for physician interpretation of medical imaging data. Facilitates diagnostic decision-making by rendering high-resolution images. Not intended for digital mammography.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

20.1-inch color LCD monitor; supports resolutions from 640x480 to 1600x1200; VESA standard compliant; includes panel, inverter, and main board components.

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

• CCL202 (Flat Panel Display, ME and CCL Series, K021738)

Submission Summary (Full Text)

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K06106/

## TOTOKU

JUN - 7 2006

## 510(k) SUMMARY

| Submitter Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mikio Hasegawa, General Manager<br>Email: [e-mail]<br>Tel:[phone]<br>Fax:[phone] |
| Date Prepared: | April 17, 2006 |
| Device Name: | 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) |
| Common Name: | CDL2009A, CCL204 |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | CCL202 (Flat Panel Display, ME and CCL Series, K021738) |
| Device Description: | CDL2009A has a multi-displaying function corresponding to the<br>resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also<br>compliant with VESA standard display mode. |
| Indended Use: | 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) 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: | CDL2009A shares the same characteristics with our predicate<br>device CCL202 (Flat Panel Display, ME and CCL Series, K021738)<br>except for the panel, inverter, and main board. |

।

CDL2009A Premarket Notification

:

・・・・・・

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Image /page/1/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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 7 2006

Mikio Hasagawa General Manager TOTOKU ELECTRIC CO., INC. 300 Oya, Ueda Nagano 386-0192 JAPAN

Re: K061061

Trade/Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 17, 2006 Received: April 17, 2006

Dear Mr. Hasagawa:

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.

*Protecting and Promoting Public Health*

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## Page 2 -

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/cdrlv/industry/support/index.html.

Sincerely vours.

Nancy C Hodgdon

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: 20.1-inch (51cm) Color ECD Monitor CDL2009A (CCL204) Indications for Use:

20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) 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. Beradon

and Rac 510(k) Numb

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