20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)

K063200 · Totoku Electric Co., Ltd. · LLZ · Dec 7, 2006 · Radiology

Device Facts

• Record ID: K063200
• Device Name: 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 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 CDL2010A (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

The CDL2010A (CCL204) is a 20.1-inch color LCD monitor designed for medical imaging. It accepts video inputs ranging from VGA (640x480) to UXGA (1600x1200) resolutions and complies with VESA display standards. The device is operated by trained medical practitioners in clinical environments to visualize diagnostic images. It functions as a display peripheral for Picture Archiving and Communication Systems (PACS). By providing high-resolution visualization, it assists clinicians in interpreting medical images to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

20.1-inch color LCD monitor; supports resolutions from 640x480 to 1600x1200; VESA standard compliant; Class II radiology device (21 CFR 892.2050).

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

• CDL2009A (K061061)

Submission Summary (Full Text)

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K065200

# 510(k) SUMMARY

DEC - 7 2006

- Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: [e-mail] Tel: [phone] Fax: [phone]

Date Prepared: October 17, 2006

- Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204)
- CDL2010A, CCL204, 2M Monitor/Display Common Name:
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: CDL2009A (K061061)
- Device Description: CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.
- Indended Use: 20.1-inch (51cm) Color LCD Monitor CDL2010A (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.
- Substantial Equivalence: CDL2010A shares the same characteristics with our predicate device CDL2009A (K061061) except for the LCD panel.

### TOTOKU ELECTRIC CO., LTD.

CDL2010A Premarket Notification

13/53 Page

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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized human figure with three wavy lines representing the body, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the figure. The logo is black and white and appears to be a scanned image.

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

DEC - 7 2006

Re: K063200

Trade/Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 20, 2006

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 Nossmetic 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 shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. The word "Centennial" is written in a cursive font below the acronym. Three stars are arranged in a horizontal line below the word "Centennial". The logo is surrounded by 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 C. Hogdon

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 LCD Monitor CDL2010A (CCL204) Indications for Use:

20.1-inch (51cm) Color LCD Monitor CDL2010A (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)

David Br. Hageman

Reproductive, Abdomir ical Devices 510(k) Nun