DAR-3000B

K973342 · Shimadzu Corp. · IZI · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K973342
• Device Name: DAR-3000B
• Applicant: Shimadzu Corp.
• Product Code: IZI · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

This device is intended to be used in Angiography in Hospital with the X-ray devices. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations.

Device Story

DAR-3000B is a digital subtraction angiography (DSA) system; used in hospital settings by physicians and X-ray technologists. Device integrates with existing X-ray equipment to capture, process, and display angiographic images. Principle of operation involves digital subtraction of X-ray images to enhance visualization of blood vessels; output provided to clinicians for diagnostic and interventional decision-making. System facilitates real-time or post-processed image review to assist in vascular procedures, potentially improving diagnostic accuracy and procedural outcomes.

Clinical Evidence

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

Technological Characteristics

Digital subtraction angiography system; designed for integration with hospital X-ray equipment. Operates as a digital imaging processing unit. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for use in angiography procedures for the total patient population. Used in hospital settings by physicians and X-ray technologists in conjunction with X-ray devices.

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

• IDR-1000 (K920720)
• DAR-2400-15B/30B (K955395)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top of the seal in a circular pattern.

- 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael Fishback Director, National Service and Regualtory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, California 90502-1328

Re:

K973342 DAR-3000B Digital Subtraction Angiography System Dated: August 28, 1997 Received: August 5, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Mr. Fishback:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

hĩ Tiau Yhi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K)Submission, DAR-3000B

Page 1 of of

Unknown 510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________

Device Name:____ DAR-3000B

Indications For Use :

· This device is intended to be used in Angiography in Hospital with the X-ray devices..

· This device is operated and used by Physicians and X-ray technologist.

· The object of this device is total patient populations.

As mentioned at "Intended Use" in this clearance letter, the intended use of the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395).

Consequently, the indications for use of the DAR-3000B are also the same as that of the IDR-1000 (K920720) and DAR-2400-15B/30B (K955395) , and there are no additional indications.

Uhrid C. Leyon

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per2TCFR801.109)

OR

Over-The-Counter Use