LIGHTLINE-M

K974240 · Wuestec Medical, Inc. · IZX · Dec 22, 1997 · Radiology

Device Facts

• Record ID: K974240
• Device Name: LIGHTLINE-M
• Applicant: Wuestec Medical, Inc.
• Product Code: IZX · Radiology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1610
• Device Class: Class 2

Intended Use

The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

Device Story

LightLine-M is a diagnostic x-ray beam-limiting device (collimator). It functions by mechanically restricting the dimensions of the primary x-ray beam to ensure the radiation field matches the area of interest. Used in clinical diagnostic radiography settings; operated by trained radiologic technologists or physicians. The device assists in minimizing patient radiation exposure by limiting the field size to the necessary diagnostic area. It serves as an accessory to x-ray imaging systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diagnostic x-ray beam-limiting device (collimator). Class II device under 21 CFR 892.1610 (Procode: IZX). Mechanical beam restriction mechanism.

Indications for Use

Indicated for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1997

Kristi White Quality Manager Wuestec Medical, Inc. 421 Holcolmbe Avenue Mobile, AL 36606

Re:

LightLine-M (Diagnostic x-ray beam-limiting device) Dated: October 17, 1997 Received: November 12, 1997 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZX

Dear Ms. White:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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.

K974240

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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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/dsmamain.html".

Sincerely yours,

W.Lilian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INTENDED USE

The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

See the following pages describing operation taken from the operator manual.

for DAS

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

**Prescription Use**
(Per 21 CFR 801.109)

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