MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

K072780 · Ralco S.R.L. · IZW · Nov 26, 2007 · Radiology

Device Facts

• Record ID: K072780
• Device Name: MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
• Applicant: Ralco S.R.L.
• Product Code: IZW · Radiology
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Device Story

Automatic X-ray beam-limiting system; multilayer square field collimator. Stepper motors drive shutter movements, additional filters, and optional round field. Microprocessor circuit controls stepper motors; provides stepless adjustment of square field dimensions at variable FFD (SID). Manual adjustment available via front panel knobs or pushbuttons. Integrated boards allow system control via CAN-Bus protocol. Used in clinical diagnostic imaging environments; operated by radiology technicians or physicians. Output consists of controlled X-ray beam geometry; assists in radiation field limitation during diagnostic procedures; benefits patient by minimizing unnecessary radiation exposure.

Clinical Evidence

Bench testing and safety laboratory testing only. No clinical data provided.

Technological Characteristics

Multilayer square field collimator; stepper motor-driven shutters/filters; microprocessor-controlled; CAN-Bus protocol connectivity. Conforms to US Performance Standards and CSA Listed to US Standards for medical device safety.

Indications for Use

Indicated for use in diagnostic radiographic and fluoroscopic applications. No specific patient population or contraindications defined.

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

• Ralco Collimator, Automatic Radiographic (K820306)
• Ralco Collimator, Automatic Radiographic (K827124)
• Advantech Model R600/800 series collimators (K904182)
• Omega Medical Imaging Model R605FACS (K050092)

Submission Summary (Full Text)

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# 510(k) Summary: K072780 RALCO srl Via dei Tigli 13/G 20046 Biassono (mi) Italy Tel. [phone] Fax: [phone] email: [e-mail] August 14, 2007 Contact person: Vincenzo Velardi, President and CEO

NOV 2 6 2007

# 1. Identification of the Device:

Proprietary-Trade Name: Model R302DACS/A Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.

- 2. Equivalent legally marketed devices: Ralco Collimator, Automatic Radiographic, Tecnomed, Inc. K820306 and K827124 (Manufactured by Ralco but sold in the US by Tecnomed); Advantech Model R600/800 series collimators manufactured by Ralco SRL under K904182; Omega Medical Imaging Model R605FACS, K050092.
- 3. Indications for Use (intended use): Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
- 4. Description of the Device: Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices.
- 6. Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the Model R302DACS/A is as safe and effective as the predicate devices, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ralco SRL % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K072780

Trade/Device Name: Model R302DACS/A Automatic X-RAY Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: September 26, 2007 Received: September 28, 2007

### Dear Mr. Kamm:

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 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/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

K072780 510(k) Number (if known):_

Device Name: Model R302DACS/A Automatic X-RAY Collimator

Indications For Use: Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aomi hin Whing

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

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