Lightline-M

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K974240 ↗

FDA Product Code

IZX

Device Class

Class II

Regulation

21 CFR Part 892.1610

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Xrt 600 R/F, Wrf 0600

  Class II

  FDA 510(k) K992603 Active Cleared 25 Oct 1999

• Xrt 400

  Class II

  FDA 510(k) K955414 Active Cleared 24 Jul 1996

• Superstand 300

  Class I

  FDA 510(k) K935123 Active Cleared 27 Mar 1996

• Dx-480, Add on Digital Imager

  Class II

  FDA 510(k) K981880 Active Cleared 20 Oct 1998

• Superstand 3000

  Class I

  FDA 510(k) K933253 Active Cleared 16 Aug 1993

• Pensil Trauma, Model WWS6100

  Class II

  FDA 510(k) K993962 Active Cleared 21 Dec 1999

See all devices from Wuestec Medical, Inc. →

• What is the Lightline-M used for in a radiology setting and how does it improve patient safety?

  The Lightline-M is a Manual Radiographic Collimator designed to precisely limit and shape the x-ray beam during diagnostic radiography. By confining radiation to the area of interest, it reduces unnecessary exposure to patients, thereby improving safety while also enhancing image quality by ensuring accurate alignment of the beam.

• Is the Lightline-M intended for single-use or reusable applications, and what does this mean for maintenance?

  The Lightline-M is explicitly supplied as a reusable component, meaning it is designed for repeated use in radiology settings. Since it is not single-use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure continued functionality and compliance with regulatory standards (e.g., 21 CFR 892.1610).

• What regulatory pathway was followed for FDA clearance of the Lightline-M, and what does this classification mean for its use?

  The Lightline-M received FDA 510(k) clearance in 1997 under the Radiology (RA) Advisory Committee, classified as a Class II device requiring special controls. This classification indicates it is subject to stricter regulatory oversight than Class I devices but does not require premarket approval (PMA), meaning it is deemed to be substantially equivalent to a legally marketed predicate device.

• Are there multiple models or sizes of the Lightline-M, and how can I identify the correct one for my facility?

  The Lightline-M is listed with multiple FEI numbers (e.g., 3023546785, 3002088145, etc.), which may correspond to different configurations or models. While the exact specifications (e.g., field sizes, mounting options) aren’t detailed in the submission, these identifiers can be cross-referenced with your facility’s existing equipment or manufacturer documentation to ensure compatibility. Contacting Wuestec Medical, Inc. directly would provide clarity on available variants.

• Does the Lightline-M come with any specific storage or handling instructions, particularly given its reusable nature?

  While the regulatory submission does not explicitly outline storage instructions, as a reusable radiographic collimator, the Lightline-M should be stored in a clean, dry environment to prevent damage or contamination. Proper cleaning and sterilization protocols (e.g., per facility or manufacturer guidelines) are critical to maintain performance and hygiene, especially in high-use radiology settings. Always refer to the manufacturer’s instructions for device-specific care.