XRE COLLIMATOR WITH SPECTRAL FILTER

K984414 · Trex Medical Corp. · IZW · Dec 30, 1998 · Radiology

Device Facts

• Record ID: K984414
• Device Name: XRE COLLIMATOR WITH SPECTRAL FILTER
• Applicant: Trex Medical Corp.
• Product Code: IZW · Radiology
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

Device Story

XRE Collimator with Spectral Filter functions as primary X-ray beam limiting device within angiographic imaging systems; provides manual or automatic control of beam geometry and filtration. Device reduces X-ray dose to patient while maintaining image quality. Operated by professional medical personnel in clinical settings. Output consists of controlled X-ray beam exposure; assists clinicians in optimizing radiation dose during angiography.

Clinical Evidence

Bench testing only.

Technological Characteristics

X-ray beam limiting device; includes spectral filtration mechanism for dose reduction; manual and automatic control interfaces; designed for integration into angiographic imaging systems.

Indications for Use

Indicated for use as a primary X-ray beam limiting device in angiographic imaging systems. Intended for operation by professional medical personnel only.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Re:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 1998

Wayne V. Loomer Director, Quality Assurance and Regulatory Affairs Trex Medical Corp. 300 Foster Street Littleton, MA 01460

Dear Mr. Loomer:

K984414 XRE Collimator with Spectral Filter Dated: December 8, 1998 Received: December 10, 1998 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZW

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification for XRE Collimator with Spectral Filter

## 14. Indications for Use Statement

510(k) Number (if known):

Device Name: XRE COLLIMATOR with Spectral Filter

Indications For Use:

The XRE Collimator with spectral filter is designed to be the primary X-ray beam limiting device as part of an angiographic imaging system and is controllable manually and automatically. It also provides a means of manual or automatic selection of filtration designed to reduce the xray dose applied to the patient while still providing high quality images. It is designed to be operated by professional medical personnel only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|----------------------------------------------------------------------------------------|---------|
| 510(k) Number | K984414 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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