SHIMADZU COLLIMATOR R-30H

K090578 · Shimadzu Corp. · IZW · Nov 6, 2009 · Radiology

Device Facts

• Record ID: K090578
• Device Name: SHIMADZU COLLIMATOR R-30H
• Applicant: Shimadzu Corp.
• Product Code: IZW · Radiology
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

The R-30H is used to take the radiography of patients. The intended for use of the R-30H are also the same as of the predicate beam limiting device R-30H (K031771).

Device Story

The R-30H is a beam-limiting device used in conjunction with radiographic x-ray systems. It functions to restrict the x-ray beam to the area of clinical interest, reducing patient radiation exposure. Operated by trained radiologic technologists or physicians in clinical settings, the device allows for precise collimation of the x-ray field. By limiting the field of view, it improves image quality through scatter reduction and minimizes unnecessary radiation dose to the patient. The device is integrated into the x-ray imaging chain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Beam-limiting device (collimator) for radiographic x-ray systems. Regulated under 21 CFR 892.1600 (Product Codes IZW, IZX). Mechanical design for x-ray field restriction.

Indications for Use

Indicated for general radiographic imaging of patients.

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.

Predicate Devices

• R-30H (K031771)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

:

Shimadžu Corporation % Mr. Don Karle Director, National Service Shimadzu Medical Systems USA 20101 South Vermont Avenue TORRANCE CA 90502

NOV - 6 2009

Re: K090578

Trade/Device Name: R-30H Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZW and IZX Dated: September 8, 2009 Received: October 7, 2009

Dear Mr. Karle:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR. Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 17

510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________

Device Name: R-30H

Intended Use :

The R-30H is used to take the radiography of patients.

The intended for use of the R-30H are also the same as of the predicate beam limiting · device R-30H (K031771).

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use
(Per21CFR801.109)

(Division Sign-Off)

Over-The-Counter Use

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