SHIMADZU COLLIMATOR R-30H

K031771 · Shimadzu Corp. · IZX · Aug 21, 2003 · Radiology

Device Facts

• Record ID: K031771
• Device Name: SHIMADZU COLLIMATOR R-30H
• Applicant: Shimadzu Corp.
• Product Code: IZX · Radiology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.

Device Story

Beam Limiting Device R-30H is a collimator used with x-ray generators and tubes. It functions by mechanically restricting the x-ray beam to a specific, confined field of view. This limits patient and staff exposure to unnecessary radiation during diagnostic imaging. Operated by radiology technicians or physicians in clinical settings, the device ensures radiation is directed only at the area of interest. By reducing the scatter and primary radiation field, it minimizes radiation dose to the patient and surrounding environment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical collimator assembly; designed for integration with x-ray generators and tubes; provides adjustable radiation field restriction; complies with 21 CFR 892.1610 diagnostic x-ray beam-limiting device standards.

Indications for Use

Indicated for use in conjunction with x-ray generators and tubes to restrict the radiation field of view for patients undergoing diagnostic x-ray procedures.

Regulatory Classification

Identification

A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Shimadzu Corporation % Mr. Takeshi Ozaki Director, National Service Shimadzu Medical Service 20101 South Vermont Avenue TORRANCE CA 90502-1328 Re: K031771

Trade/Device Name: Beam Limiting Device R-30H Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beamlimiting device Regulatory Class: II Product Code: 90 IZX Dated: August 6, 2003 Received: August 8, 2003

Dear Mr. Ozaki:

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 (PMA), it may be subject to 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 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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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(63/77 510(k) Number(if known): Device Name - Beam limiting device R-30H

Indication For Use:

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general

population in the exam area.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

David G. Segner

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

(Optional format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)