DAR-8000F

K052500 · Shimadzu Medical Systems · IZI · Oct 17, 2005 · Radiology

Device Facts

• Record ID: K052500
• Device Name: DAR-8000F
• Applicant: Shimadzu Medical Systems
• Product Code: IZI · Radiology
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

This device is intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist.

Device Story

The DAR-8000f is an angiographic X-ray system used in hospital settings for radiographic imaging. It is operated by physicians and X-ray technologists. The device functions as an X-ray imaging system, capturing radiographic data to assist in clinical diagnostic procedures. It is intended for the total patient population. The system is substantially equivalent to the DAR-7000 (K050925).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Angiographic X-ray system. Classified under 21 CFR 892.1600 (Product Code IZI).

Indications for Use

Indicated for the total patient population requiring radiography in a hospital setting using X-ray devices. Operated 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

• DAR-7000 (K050925)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randal Walker Director, National Service Shimadzu 20101 South Vermont Ave. TORRANCE CA 90502-1328 Re: K052500 Trade/Device Name: DAR-8000f Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: September 9, 2005 Received: September 14, 2005

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.

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.

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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 premated 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 11 70a debtro of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR | | |
|-----------------|----------------------------------|--------------|
| 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 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7 ). " Canal Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) Notification Submission, DAR-8000f

Page 31

SECTION XIII: INDICATION FOR USE

510(k) Number(if known): Unknown K052500

Device Name: DAR-8000f

Indication for use :

/ This device is intended to be used for the radiography in the hospital with X-ray devices.

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

/ The object of this device is total patient population.

As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925).

Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, 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)

| Prescription Use |
|--------------------|
| (Per21 CFR801.109) |

OR
Over-The-Counter Use
Nancy C. Bridgdon

(Division Sign Division of Reproductive and Radiological Devic 510(k) Number