R605 FACS COLLIMETER

K050092 · Omega Medical Imaging, Inc. · IZW · Jan 31, 2005 · Radiology

Device Facts

• Record ID: K050092
• Device Name: R605 FACS COLLIMETER
• Applicant: Omega Medical Imaging, Inc.
• Product Code: IZW · Radiology
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Device Story

The Omega R605 FACS is an automatic radiographic/fluoroscopic collimator used in diagnostic imaging. It features continuous round field shutters and an additional lung filter specifically for cardiac applications. The device functions to limit the X-ray beam to the area of interest, reducing patient radiation exposure. It is intended for use by clinical professionals in diagnostic imaging environments. The device complies with federal and international safety standards for X-ray beam-limiting devices.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and compliance with safety standards.

Technological Characteristics

Automatic radiographic/fluoroscopic collimator; features continuous round field shutters and cardiac lung filter. Complies with 21 CFR 1020.30, 1020.31, 1020.32; IEC 60601-1, 60101-1-2, 60601-1-3; UL 60601-1; CAN/USA C22.2 No.601.1-M90.

Indications for Use

Indicated for use in diagnostic radiographic/fluoroscopic applications.

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

• Dunlee automatic "FORMAT A" collimator (K031597)
• Advantech Model R600/800 series collimators (K904182)

Submission Summary (Full Text)

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## OMEGA MEDICAL IMAGING, INC.

K050092

### 510(k) SUMMARY

JAN 3 1 2005

| Company Name: | Omega Medical Imaging, Inc |
|----------------------|---------------------------------------------------------------------------------------|
| Address: | 675 Hickman Circle<br>Sanford, FL 32771 |
| Telephone No: | 407-323-9400 |
| Registration No.: | 1052701 |
| Contact person: | James A. Princehorn |
| Date Prepared | 3 January 2005 |
| Device (trade) name: | Automatic Beam-limiting Device Model R605FACS |
| Classification name: | Diagnostic X-Ray Beam-Limiting Device (21 CFR 892.1610)<br>Class II (Procode: 90 IZW) |
| Common/usual name: | Automatic Radiographic/fluoroscopic Collimator |

#### Predicate device:

- Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally . marketed under number K031597.
- marketed under number Roo roof :
Advantech Model R600/800 series collimators manufactured by RALCO S.R.L. legally marketed . under number K904182

#### Device description:

Device desoription:
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.

#### Intended use:

- The Omega R605 FACS automatic collimator is intended for use in diagnostic . radiographic/fluoroscopic applications.
#### Safety information:

- mornation.
The Omega R605 FACS collimator will comply with the applicable requirements of 21 CFR . 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega R605 FACS collimator will comply with the international safety standards IEC . 60601-1, IEC 60101-1-2, and IEC 60601-1-3.
- The Omega R605 FACS will comply with CE Marking requirements. .
- The Omega R605 FACS will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .

#### Conclusion:

Oonega R605 FACS collimator does not introduce any new indications for use, nor does the use of The Omoga Rood Proo Considers the R605 FACS collimator the R605 FACS collimator to be substantially equivalent with the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771

Re: K050092 Trade/Device Name: Omega R605 FACS automatic collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray Beam-limiting device Regulatory Class: II Product Code: 90 IZW Dated: January 5, 2005 Received: January 14, 2005

Dear Mr. Princehorn:

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.

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.

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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.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" (21 CFR 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/cdrh/dsmadsmam.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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Omega Medical Imaging, Inc.

K050092

# Omega R605 FACS Collimator

## Indications for Use:

The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

*Prescription Use*

David G. Ingram