RALCO, MODEL R225 ACS

K091517 · Ralco S.R.L. · IZW · Jul 14, 2009 · Radiology

Device Facts

• Record ID: K091517
• Device Name: RALCO, MODEL R225 ACS
• Applicant: Ralco S.R.L.
• Product Code: IZW · Radiology
• Decision Date: Jul 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Device Story

The Model R225 ACS is a multilayer, square-field automatic X-ray collimator used in diagnostic radiographic and fluoroscopic systems. It functions by controlling the X-ray beam geometry via stepper motors that adjust internal shutters and an additional filter. The device features a mounting plane at 80 mm from the focus. A microprocessor circuit manages the stepper motors to provide stepless adjustment of square field dimensions at variable focus-to-film distances (FFD/SID). Field dimensions are adjusted via manual knobs on the front panel. The device is operated by clinical staff in a diagnostic imaging environment. By automating beam limitation, it ensures precise X-ray field sizing, which helps optimize radiation exposure and image quality for the patient.

Clinical Evidence

Bench testing only. No clinical data was required or provided. The device was validated through laboratory and safety testing to confirm it meets US performance standards for diagnostic X-ray beam-limiting devices.

Technological Characteristics

Multilayer, square-field automatic collimator. Features stepper motor-driven shutters and filter. Microprocessor-controlled adjustment of field dimensions at variable FFD/SID. Mounting plane at 80 mm (3.15") from focus. Manual adjustment knobs provided. Conforms to US Performance Standards for diagnostic X-ray beam-limiting devices (21 CFR 892.1610). CSA listed for medical device safety.

Indications for Use

Indicated for use in diagnostic radiographic and fluoroscopic applications for patients requiring X-ray imaging.

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 Model R302DACS Automatic Collimator (K072780)

Submission Summary (Full Text)

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### RALCO srl Via dei Tigli 13/G 20046 Biassono (mi) Italy Tel. [phone] Fax: [phone] email: [e-mail] Date prepared: May 18, 2009 Contact person: Vincenzo Velardi, President and CEO

#### 1. Identification of the Device:

Proprietary-Trade Name: Model R225 ACS Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.

- Equivalent legally marketed devices: K072780, Ralco Model R302DACS Automatic Collimator. 2.
- Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications. 3.
- Description of the Device: This x-ray collimator Multilayer, square-field, automatic collimation 4. system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
- Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and 5. laboratory testing indicates that the new device is as safe and effective as the predicate device. The predicate employs a round field, same as our new device. The new device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices.
- Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the . 6. Model R225 ACS is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

Image /page/0/Figure/10 description: The image shows two different devices, labeled "Predicate" and "R225 ACS". Both devices are cube-shaped with control panels on the front. The "Predicate" device has a keypad and knobs, while the "R225 ACS" device has a display screen, buttons, and knobs.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUI 1 4 2009

RALCO, srl % Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Rd. DEERFIELD IL 60015

Re: K091517

Trade/Device Name: Model R225 ACS Automatic Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: May 20, 2009 Received: June 02, 2009

#### 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 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 (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 hitp://www.fda.gov/cdrh/mdr/ 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/cdrh/industry/support/index.html.

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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510(k) Number (if known): K09 / S17

Model R225 ACS Automatic Collimator Device Name:

Indications For Use:

Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Prescription Use × (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)

Hubert Reever

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

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