DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 0 2004 Mr. Takeshi Ozaki Director, National Service Shimadzu Medical Systems 20101 South Vermont Ave. TORRANCE CA 90502-1328 Re: K032443 Trade/Device Name: DAR-5000 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: December 17, 2004 Received: December 24, 2004 Dear Mr. Ozaki: 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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 {2}------------------------------------------------ ## 11032443 Notification Submission, DAR-5000 510(K) Page 18 | SECTION XIII: | INDICATION FOR USE | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br> | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A<br>Company of Concession Comments of Children Comments of<br>and the a more of the are a may be a free | Page1 of1 510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________ Unknown DAR-5000 Device Name: Indications For Use : - / This device is intended to be used in the Angiography in Hospital with the X-ray devices. - This device is operated and used by Physicians and X-ray technologist. 1 - / The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-5000 is the same as that of predicate device DAR-2400-15B/30B (K955395). Consequently, the indications for use of the DAR-5000 are also the same as that of the DAR-2400-15B/30B (K955395), and there are no additional indications. (Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED ) Concurrence of CDRH, Office of Device Evaluation(ODE) Prescription Use (Per21CFR801.109) OR Over-The-Counter Use David R. Legum and the submit and the submit of the submit of the subsequence of and Radiological Devic 510/k) Numb