BRANSIST SAFIRE

K062360 · Shimadzu Corp. · IZI · Oct 5, 2006 · Radiology

Device Facts

• Record ID: K062360
• Device Name: BRANSIST SAFIRE
• Applicant: Shimadzu Corp.
• Product Code: IZI · Radiology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Indications for Use

This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices. This device is operated and used by physicians and X-ray Technologists.

Device Story

BRANSIST Safire is an angiographic X-ray system used for diagnostic imaging of the circulatory vascular system. The system captures X-ray images of the heart, blood vessels, or lymphatic system following contrast medium injection. It operates in conjunction with a positioning device and other auxiliary equipment. The device is intended for use by physicians and X-ray technologists in a clinical setting. By providing high-quality visualization of vascular structures, the system assists clinicians in diagnosing circulatory conditions. The device functions as a standard angiographic X-ray system under 21 CFR 892.1600.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Angiographic X-ray system; 21 CFR 892.1600; utilizes X-ray imaging for vascular visualization; designed for integration with patient positioning hardware.

Indications for Use

Indicated for radiologic visualization of the heart, blood vessels, or lymphatic system during or after contrast medium injection for diagnosis of the circulatory vascular system.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT - 5 2006

Mr. Randall Walker Director. North American Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

Re: K062360

Trade/Device Name: BRANSIST Safire Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class II Product Code: IZI Dated: July 31, 2006 Received: August 15, 2006

Dear Mr. Walker:

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 (Premarket Approval), 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.

Image /page/0/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, "PA" in the center, and "Centennial" at the bottom. There are three dots below the word "Centennial". The logo appears to be a commemorative emblem, possibly for an organization's 100th anniversary.

Protecting and Promoting Public Health

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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 10gally 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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 from the Division of Small Manufacturers, International and Consumer Assistances at its toll-free number [phone] or [phone]

or at its Internet address littp://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BRANSIST Safire

Section XIII: INDICATION FOR USE

510(k) Number: Unknown K062360

Device name: BRANSIST Safire

Indication for use:

This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positin ing device and other devices.

This device is operated and used by physicians and X-ray Technologists.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lynam

sion of Reproduct and Radiological Devi 510(k) Numbe

Prescription Use_