20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB

K050619 · Totoku Electric Co., Ltd. · LLZ · Apr 26, 2005 · Radiology

Device Facts

• Record ID: K050619
• Device Name: 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Device Story

20.8-inch color LCD monitor; supports DVI video input; provides QXGA (2048 x 1536) resolution; landscape or portrait orientation. Used in clinical settings with PACS for viewing medical images. Operated by healthcare professionals. Device incorporates a front sensor for display calibration/monitoring. Output allows clinicians to visualize diagnostic images to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

20.8-inch color LCD monitor; QXGA (2048 x 1536) resolution; DVI video interface; includes integrated front sensor for display monitoring/calibration.

Indications for Use

Indicated for use in conjunction with PACS for medical imaging applications. Not indicated for digital mammography. Patient population not specified.

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

• CDL2114A (K043430)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "TOTOKU" in bold, black letters. The letters are large and spaced closely together. A double line is present underneath the word.

K050419

## 510(k) SUMMARY

- TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Nagano 386-0192 Japan
Mikio Hasegawa, General Manager Contact Person: Email: [e-mail] +81.268.34.5469 Tel: Fax: [phone]

Date Prepared: March 7, 2005

- 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) Device Name:
CDL2112A, CCL350i, DV3MC-HB, 3M Monitor/Display Common Name:

- Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: CDL2114A (K043430)

- CDL2112A (CCL350i) (DV3MC-HB) is a 20.8-inch Color LCD Monitor that Device Description: supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
- 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to Intended Use: be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
- Substantial Equivalence: CDL2112A (CCL350i) (DV3MC-HB) has almost the same characteristics as TOTOKU's predicate device CDL2114A (K043430) except for the molds, the LCD panel, and the front sensor, which has been newly placed.

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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boullevard Rockville MD 20850

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

Re: K050619 Trade/Device Name: 20.8-inch (53cm) Color Monitor CDL2112A (CCL350i) (DV3MC-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 7, 2005 Received: March 10, 2005

Dear Ms. 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.

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.

## APR 2 6 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter with and on. The FDA finding of substantial equivalence of your device to a legally promatics notified in " 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.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" (21 CFR 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/cdrh/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

Enclosure

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## INDICATIONS FOR USE

510(k) Number: Not Known

Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB). Indications for use:

20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

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)

Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K050619
510(k) Number