← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K050616 # 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB (K050616) _Totoku Electric Co., Ltd. · LLZ · Apr 21, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050616 ## Device Facts - **Applicant:** Totoku Electric Co., Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Apr 21, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-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 21.3-inch color LCD monitor; supports DVI video input; provides UXGA (1600 x 1200) resolution; landscape or portrait orientation. Used in clinical settings by healthcare professionals for viewing medical images via PACS. Includes a front sensor for display calibration/monitoring. Output allows clinicians to visualize diagnostic images to support clinical decision-making. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics 21.3-inch color LCD monitor; UXGA (1600 x 1200) resolution; DVI video interface; front sensor integration for display monitoring. ## Regulatory 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 - CDL2107A ([K040697](/device/K040697.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ APR 2 1 2005 K050616 ## 510(k) SUMMARY - Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan - Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5565 Date Prepared: March 7, 2005 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) Device Name: Common Name: CDL2113A, CCL250i, DV2MC-HB, 2M Monitor/Display - Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: CDL2107A (K040697) - CDL2113A (CCL250i) (DV2MC-HB) is a 21.3-inch Color LCD Monitor that Device Description: supports DVI video signal and provides UXGA (1600 x 1200) resolution for both landscape and portrait display. - 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-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. - CDL2113A (CCL250i) (DV2MC-HB) has almost the same characteristics as Substantial Equivalence: TOTOKU's predicate device CDL2107A (K040697) except for the molds and the front sensor, which has been newly placed. CDL2113A Premarket Notification 1. 1 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 1 2005 Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN Re: K050616 Trade/Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems ﺎ Regulatory Class: II Product Code: LLZ Dated: March 7, 2005 Received: March 10, 2005 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 the cholors') to regary mant date of the Medical Device Amendments, or to devices that have been rear 20, 1770, are cance 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 do not require approval controls provisions of the Act. The general controls provisions of the Act de nee, subject to the genual 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 11 your de read it a such additional controls. Existing major regulations affecting your Apployal), It ifal 700 books 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 I loase or devised 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 I cara suiteres and regularing, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modeling practice requirements as set forth in the quality systems (QS) (21 CFR Part 80 7) good million the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 5 0 local i his letter will anow you to ocgin maneting of substantial equivalence of your device to a legally premarket notification. The PDA moning of Sacstantial vijas and thus, permits your device to procced to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device on our lacenting org 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 prematic notification the Act frem the Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). You may obtain other general information of the summer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 056-2011-01-01-25 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 . {3}------------------------------------------------ # 1010 ## INDICATIONS FOR USE 510(k) Number: Not Known Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB). Indications for use: 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-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 (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) Nancy Broaddus IDivision Sign-Division of Reproduc and Radiological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050616](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K050616) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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