21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)

K113136 · Totoku Electric Co., Ltd. · LLZ · Dec 20, 2011 · Radiology

Device Facts

• Record ID: K113136
• Device Name: 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
• Applicant: Totoku Electric Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL256i2 (CL21256) 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

The CCL256i2 is a 21.3-inch color LCD monitor designed for medical image display. It accepts digital video inputs via DVI and Display Port interfaces. The device functions as a high-resolution display terminal for medical practitioners to view diagnostic images in clinical settings. It does not perform image processing or automated analysis; it serves as a visual output interface for PACS or other imaging systems. The monitor aids clinicians in diagnostic decision-making by providing high-fidelity image visualization. It is not intended for digital mammography applications.

Clinical Evidence

Bench testing only.

Technological Characteristics

21.3-inch (54 cm) color LCD monitor; 1200 x 1600 (landscape) or 1600 x 1200 (portrait) resolution; DVI and Display Port connectivity; power supply modification compared to predicate.

Indications for Use

Indicated for display and viewing of medical images for diagnostic purposes by trained medical practitioners. 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

• 21.3 inch (54 cm) Color LCD Monitor CCL254i2 (CDL2125A) (K081055)

Submission Summary (Full Text)

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# TOTOKU

K113136

.

# 510(k) SUMMARY

DEC 2 0 2011

| Submitted Information: | TOTOKU ELECTRIC CO., LTD.<br>300 Oya, Ueda<br>Nagano 386-0192 Japan |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | October 21, 2011 |
| Device Name: | 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256) |
| Common Name: | CCL256i2, CL21256 |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Color LCD Monitor CCL254i2 (CDL2125A)<br>(K081055) |
| Device Description: | CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor<br>whose display resolution is 1200 x 1600 (landscape), 1600 x 1200<br>(portrait) supporting DVI (digital visual interface) and Display Port. |
| Intended Use: | 21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL256i2 (CL21256)<br>is intended to be used in displaying and viewing medical images<br>for diagnosis by trained medical practitioners. It is not meant to be<br>used for digital mammography. |
| Substantial Equivalence: | CCL256i2 (CL21256) shares the same characteristics with our<br>predicate device CCL254i2 (K081055) except for the power supply. |

TOTOKU ELECTRIC CO., LTD. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 Japan

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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr.Tsukasa Tashiro General Manager TOTOKU Electric Co., LTD 300 Ova 386-0192 UEDA NAGANO JAPAN

DEC 2 0 2011

Re: K113136

Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21, 2011 Received: October 24, 2011

Dear Mr. Tashiro:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

:510(k) Number (if known):_K113136

Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256)

Indications for Use:

21.3 inch (54 cm) Color 2M pixel LCD Monitor CCL256i2 (CL21256) is intended 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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Muhal D. Jha

Office of In Vit

ETOK

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