COLLIMATOR, MODEL M-38

K062788 · Umi International · KPW · Dec 28, 2006 · Radiology

Device Facts

• Record ID: K062788
• Device Name: COLLIMATOR, MODEL M-38
• Applicant: Umi International
• Product Code: KPW · Radiology
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.

Device Story

Manual collimator; beam-limiting device for diagnostic x-ray systems. Restricts primary x-ray beam dimensions to control field size. Operated manually by radiology technicians or clinicians in clinical settings. Output is physical restriction of radiation field; assists in minimizing patient radiation exposure by limiting beam to area of clinical interest.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual drive collimator; beam-limiting assembly for diagnostic x-ray systems. Mechanical construction; no software or electronic processing components described.

Indications for Use

Indicated for use as a diagnostic x-ray beam-limiting device to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam in x-ray systems.

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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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three wavy lines emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Kwang C. Jung President UMI International P.O. Box 170 NORWOOD NJ 07648

DEC 2 8 2006

Re: K062788

Trade/Device Name: Collimator (manual drive) – a beam limiting device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KPW Dated: December 4, 2006 Received: December 6, 2006

Dear Mr. Jung:

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.

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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/cdrlv/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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## ್ರಿ UMI International

P. O. Box 170 Norwood, NJ 07648, U.S.A. Tel [phone] Fax [phone]

## Statement of Indications for Use

510(k) Number( if known ) Device Name : Collimator( manu - a beam limiting device Indications for Use :

A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.

Prescription use
( Part 21. CFR 801 Subpart D )

and/or

Over the-Counter Use ( 21 CFR 801 Subpart C )

( Please don not write below this line - Continue on another page if needed )

Concurrence of CDRH, Office of Device Evaluation( ODE )

Nancy C. Boydon
(Division Sign-Off)

Division of Reprod and Radiological Device 510(k) Numb

( Posted Nov. 13, 2003 )

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