21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)

K081056 · Totoku Electric Co., Ltd. · LLZ · Jun 4, 2008 · Radiology

Device Facts

• Record ID: K081056
• Device Name: 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jun 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is intended 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

21.3-inch (54 cm) 3-megapixel color LCD monitor; accepts DVI video signals; provides UXGA (1536 x 2048) resolution in landscape or portrait orientation. Used by trained medical practitioners in clinical settings to view medical images for diagnosis. Output allows clinicians to visualize diagnostic data; supports clinical decision-making by providing high-resolution image display. Excludes digital mammography applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

21.3-inch (54 cm) color LCD monitor; 3-megapixel resolution; UXGA (1536 x 2048); DVI video input; landscape/portrait orientation support.

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

• 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065)

Submission Summary (Full Text)

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K08/056

JUN - 4 2008

## 510(k) SUMMARY

- 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: March 17, 2008

- Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A)
- Common Name: CCL354i2, CDL2126A
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065)

Device Description: CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.

- Indended Use: 21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is intended 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.
- CCL354i2 (CDL2126A) shares the same characteristics with our Substantial Equivalence: predicate device CCL352i2 (CDL2119A) (K072065) except for power supply, front bezel, frame, fan, PCB and LCD screen.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2008

Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN

Re: K081056

Trade/Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 2, 2008 Received: April 14, 2008

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 (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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## INDICATIONS FOR USE

510(k) Number: Not Known

Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) Indications for Use:

21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in 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)

Amst. M. Why
(Division Sign-Off)

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