COLLIMARE COLLIMATOR FAMILY

K073124 · Collimare, LLC · IZW · Nov 16, 2007 · Radiology

Device Facts

• Record ID: K073124
• Device Name: COLLIMARE COLLIMATOR FAMILY
• Applicant: Collimare, LLC
• Product Code: IZW · Radiology
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1610
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.

Device Story

Collimare Collimator Family controls x-ray beam geometry for diagnostic imaging equipment; adaptable to portable or fixed radiographic and fluoroscopic systems. Device features include rectangular, square, or circular shuttering; light simulation; spectral and wedge filters; input port shuttering; dose measurement; and laser alignment lines or mechanical/digital SID measurement. Operated by radiology personnel in clinical settings to define the x-ray field, ensuring radiation is limited to the area of clinical interest. Output consists of physical beam restriction and visual alignment aids, assisting clinicians in optimizing image quality while minimizing patient radiation exposure.

Clinical Evidence

Bench testing only. Device compliance verified against 21 CFR 1020.30, .31, & .32 (X-Ray Performance Standards), UL 60601-1 (Medical Electrical Equipment Safety), and IEC 60825-1 (Laser Safety).

Technological Characteristics

Beam-limiting device for diagnostic x-ray systems. Features include mechanical/digital shutters, spectral/wedge filters, laser alignment, and SID measurement. Energy source: electrical (for light/laser/digital components). Standards: 21 CFR 1020.30-32, UL 60601-1, IEC 60825-1. Connectivity: integrated into x-ray system. Sterilization: N/A.

Indications for Use

Indicated for use in controlling x-ray beams during diagnostic radiographic and fluoroscopic procedures on various x-ray systems. No specific patient population, age, or gender restrictions provided.

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

• X-Ray Collimating Devices (K810598)
• AXT150MC (K972966)

Submission Summary (Full Text)

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K073/24

Image /page/0/Picture/1 description: The image contains a logo and the word "Collimare". The logo is on the left side of the image and consists of a stylized design with lines and bars. The word "Collimare" is on the right side of the image and is written in a simple, sans-serif font. The text is black and the background is white.

NOV 1 6 2007

## 510(k) Summary

| Date: | August 24, 2007 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Submitter: | Collimare, LLC<br>13406 W 60 ^TH PL<br>Arvada, CO 80004 |
| Contact: | Howard C. Thomas, President |
| Phone: | [phone] |
| Fax: | [phone] |
| Common Device Name: | Manual or Automatic Collimator |
| Trade Name: | Collimare "Collimator Family" |
| Classification Name: | Diagnostic X-ray Beam Limiting Device |
| Classification Regulation Number: | IZX & IZW |
| Classification Committee/Panel: | Radiology |
| Predicate Devices: | X-Ray Collimating Devices K810598<br>Manufactured by Eureka X-Ray Tube<br>AXT150MC K972966 Manufactured<br>by Applied X-Ray Technologies |

Description: The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.

Intended Use: The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.

Performance Standards / Safety Information: X-Ray Performance Standard 21 CFR Section 1020.30, .31 & .32 // UL 60601-1 Standard for Safety, Medical Electrical Equipment // IEC 60825-1 Ed: 1 Safety of laser products - Part 1: Equipment classification and requirements

> Collimare, LLC 13406 W 60™ PL Arvada, CO 80004 P: 303.955.3091 F: 303.955.3092

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem featuring three wavy lines above a bird-like figure, all rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 6 2007

Collimare LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K073124

Trade/Device Name: Collimare "Collimator Family" Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW and IZX Dated: November 5, 2007 Received: November 6, 2007

Dear Mr. Job:

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 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

510(k) Number (if known): KC73124

Device Name: _Collimare "Collimator Family"

Indications for Use:

The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hore 75 Wtz

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(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
K073124