15-INCH (38 CM) COLOR LCD MONITOR CDL1576A

{0}------------------------------------------------ K080952 MAY 2 9 2008 # 510(k) SUMMARY - Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan Contact Person: Mikio Hasegawa, General Manaqer Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548 - Date Prepared: March 17, 2008 - Device Name: 15-inch (38 cm) Color LCD Monitor CDL1576A - Common Name: CDL1576A - Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) - Predicate Device: 15-inch (38 cm) Color LCD Monitor CDL1566A (K060961) - Device Description: CDL1576A is a 15-inch (38cm) Color LCD monitor with high luminance (350cd/ m² (typ.)) and high contrast screen (700:1 contrast ratio). 15-inch (38cm) Color LCD monitor is to be used with FUJINON endorscope system, and is manufactured exclusive for FUJINON. - Indended Use: 15-inch (38cm) Color LCD Monitor CDL1576A 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. - Substantial Equivalence: CDL1576A shares the same characteristics with our predicate device CDL1566A (K060961) except for front bezel, back enclosure and power supply. Page {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### MAY 2 9 2008 Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN Re: K080952 Trade/Device Name: 1.3M Color LCD Monitor CDL1576A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code; LLZ Dated: March 17, 2008 Received: April 3, 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. {2}------------------------------------------------ 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" (21 CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html. Sincerely vours. Nancy Brogdon 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}------------------------------------------------ ## INDICATIONS FOR USE 510(k) Number: Not-Known K080952 Device Name: 1.3M Color LCD Monitor CDL1576A Indications for Use: 15-inch (38cm) Color LCD Monitor CDL1576A 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) Tony In Wham Division of Reproductive, Abdominal and Radiological Device 510(k) Number