DAR-8000I

K052076 · Shimadzu Medical Systems · IZI · Sep 2, 2005 · Radiology

Device Facts

• Record ID: K052076
• Device Name: DAR-8000I
• Applicant: Shimadzu Medical Systems
• Product Code: IZI · Radiology
• Decision Date: Sep 2, 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 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.

Device Story

DAR 8000i is an angiographic X-ray system and Picture Archiving and Communication System (PACS). It functions as a diagnostic imaging tool for hospital radiography. Operated by physicians and X-ray technologists, the device captures, processes, and manages X-ray images. It integrates with existing hospital X-ray equipment to facilitate clinical imaging workflows. The output provides visual diagnostic data to assist healthcare providers in clinical decision-making and patient assessment.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Angiographic X-ray system and PACS. Functions as a diagnostic imaging device. Operates within hospital environments. Connectivity includes integration with X-ray imaging hardware.

Indications for Use

Indicated for radiography in hospital settings for the total patient population. 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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Mr. Randel Walker Director, National Service Shimadzu 20101 South Vermont Ave. TORRANCE CA 90502-1328

## Re: K052076

Trade/Device Name: DAR 8000i Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: IZI and LLZ Dated: July 25, 2005 Received: August 2, 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) I ms letter unf and in your he FDA finding of substantial equivalence of your device to a legally prematics notification: - 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 rr you desire sportio de need 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 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57). I od may overnment 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. Brogdon

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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## Indications for Use

510(k) Number (if known):__K052076

Device Name:__________________________________________________________________________________________________________________________________________________________________ DAR 8000i

Indications For Use:

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

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

The object of this device is total patient population. /

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use = (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Edward R. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052076