DAR-9400F

K072006 · Shimadzu Corp. · IZI · Aug 31, 2007 · Radiology

Device Facts

• Record ID: K072006
• Device Name: DAR-9400F
• Applicant: Shimadzu Corp.
• Product Code: IZI · Radiology
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

This device is intended to be used in the diagnosis of circulatory vascular system. This device is operated and used by the physicians and X-ray technologist.

Device Story

The DAR-9400f is an angiographic x-ray system used for diagnostic imaging of the circulatory vascular system. Operated by physicians and X-ray technologists in clinical settings, the device captures x-ray images to assist in vascular diagnosis. It functions as an angiographic imaging platform, providing visual data to healthcare providers to support clinical decision-making regarding vascular conditions. The device is intended to provide diagnostic information similar to established predicate angiographic systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use comparisons to predicate devices.

Technological Characteristics

Angiographic x-ray system; Class II device (21 CFR 892.1600); Product Code IZI. System utilizes x-ray imaging technology for vascular diagnosis.

Indications for Use

Indicated for use in the diagnosis of the circulatory vascular system by physicians and X-ray technologists.

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.

Predicate Devices

• BRANSIST safire (K062360)
• DAR-8000f (K052500)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three wavy lines that resemble a bird or abstract human figures. The seal appears to be from a government agency related to health and human services in the United States.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## AUG 3 1 2007

Shimadzu Corporation c/o Mr. Don Karle Shimadzu Medical Systems 20101 South Vermont Ave. TORRANCE CA 90502

Re: K072006

Trade/Device Name: DAR-9400f Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: June 15, 2007 Received: July 23, 2007

## Dear Mr. Karle:

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 shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written. Three stars are arranged at the bottom of the logo.

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 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 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 Assistance at its toll-free number [phone] or [phone]

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

Sincerely vours.

Nancy C. Hogdon

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

Enclosure

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K072006

510(k) Notification Submission, DAR-9400f

Page 21

INDICATION FOR USE SECTION XIII:

510(k) Number(if known):

Device Name: DAR-9400f

Indication for use :

/ This device is intended to be used in the diagnosis of circulatory vascular system.

/ This device is operated and used by the physicians and X-ray technologist.

As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-9400f is the same as that of predicate device of BRANSIST safire (K062360) and DAR-8000f (K052500).

Consequently, the indications for use of DAR-9400f are also the same as that of BRANSIST safire (K062360) and DAR-8000f (K052500) and there are no additional indications.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescfiption Use (Per21 CFR801.109)

| OR | TWhen Over-The-Counter Use |
|-----------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K072006 |