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.

Device Description

CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256)". It is a notification to the FDA of the intent to market the device, claiming substantial equivalence to a predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing.

This document is primarily a regulatory submission for a display monitor intended for viewing medical images. The substantial equivalence claim is based on the device sharing the same characteristics as a predicate device (CCL254i2, K081055) except for the power supply.

Therefore, I cannot provide the requested information from the given text.

Here's why:

No acceptance criteria: The document lists the device's technical specifications (e.g., screen size, resolution, interfaces) and its intended use, but it does not specify any measurable performance targets or thresholds that would typically be described as "acceptance criteria" for image quality, accuracy, or other clinical metrics.
No study details: Since it's a display monitor, performance studies would typically involve evaluating factors like luminance, contrast ratio, uniformity, color accuracy, viewing angle, and stability, often against industry standards (e.g., DICOM Part 14, AAPM TG-18). This document does not describe any such study, its methodology, results, sample sizes, expert involvement, or ground truth.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" would likely refer to internal testing performed by the manufacturer to ensure the display meets its own design specifications and relevant industry standards for medical image viewing. However, none of that information is included in this 510(k) summary.

Summary

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TOTOKU

K113136

510(k) SUMMARY

DEC 2 0 2011

Submitted Information:	TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan
Contact Person:	Tsukasa Tashiro, General ManagerEmail: tasirot@totoku.co.jpTel: +81.258.24.6611Fax: +81.258.24.6617
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(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	21.3 inch (54 cm) Color LCD Monitor CCL254i2 (CDL2125A)(K081055)
Device Description:	CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitorwhose display resolution is 1200 x 1600 (landscape), 1600 x 1200(portrait) supporting DVI (digital visual interface) and Display Port.
Intended Use:	21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL256i2 (CL21256)is intended to be used in displaying and viewing medical imagesfor diagnosis by trained medical practitioners. It is not meant to beused for digital mammography.
Substantial Equivalence:	CCL256i2 (CL21256) shares the same characteristics with ourpredicate 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).