FLUOBEAM LX Imaging System (FB-LX); FLUOBEAM LX Red Imaging System (FB-LXR)

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

510(k) Number

K233564 ↗

FDA Product Code

QDG

Models / Variants

FLUOBEAM® LX Imaging System (FB-LX)

FLUOBEAM® LX Red Imaging System (FB-LXR)

Device Class

Class II

Regulation

21 CFR Part 878.4550

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Fluobeam LX Imaging System (FBLX); Fluobeam LM Imaging System (FBLM)

  Class II

  CE/MDR FDA 510(k) K250455 Active Cleared 17 Apr 2025

• What types of surgical procedures can the Fluobeam LX Imaging System be used for, and how does it improve precision during those procedures?

  The Fluobeam LX Imaging System is designed for use in operating rooms during general and plastic surgery procedures. It enhances surgical precision by providing real-time near-infrared (NIR) fluorescence imaging of tissue, specifically highlighting anatomical structures like parathyroid glands. The FB-LX detects intrinsic tissue autofluorescence, while the FB-LX Red Imaging System also detects fluorescence after Indocyanine Green (ICG) injections, improving visualization and aiding in accurate identification of critical structures during surgery.

• Are the Fluobeam LX Imaging Systems reusable, and if so, what kind of maintenance or sterilization is required?

  Yes, the Fluobeam LX Imaging Systems are reusable medical devices. Since they are intended for sterile or semi-sterile environments, they must be properly cleaned, maintained, and sterilized according to standard surgical imaging equipment protocols to ensure safety and functionality. The manufacturer’s guidelines should be followed for specific sterilization procedures.

• How do the Fluobeam LX and Fluobeam LX Red Imaging Systems differ in their imaging capabilities?

  The Fluobeam LX Imaging System relies on autofluorescence to visualize tissue structures, such as parathyroid glands, by detecting natural fluorescence signals emitted by the tissue itself. In contrast, the Fluobeam LX Red Imaging System builds on this capability by also detecting fluorescence after the administration of Indocyanine Green (ICG), a contrast agent. This dual approach allows the FB-LXR to provide enhanced imaging clarity in cases where additional contrast is needed.

• What storage conditions should be followed for the Fluobeam LX Imaging Systems to ensure optimal performance?

  The Fluobeam LX Imaging Systems should be stored and handled according to standard protocols for surgical imaging equipment. Since they are reusable and intended for sterile or semi-sterile environments, they must be kept in a clean, controlled environment to prevent contamination. Specific storage instructions, including temperature and humidity considerations, should be referenced in the manufacturer’s documentation to maintain functionality and compliance with regulatory requirements.

• What regulatory pathways have the Fluobeam LX Imaging Systems undergone, and what does this mean for their use in clinical settings?

  The Fluobeam LX Imaging Systems have undergone FDA 510(k) clearance and comply with the Medical Device Regulation (MDR) requirements in the EU. The FDA clearance indicates that the devices are deemed substantially equivalent to a legally marketed predicate device, while MDR compliance ensures they meet stringent EU safety, performance, and regulatory standards. This means they can be legally marketed and used in their intended clinical settings, provided they are operated and maintained according to manufacturer guidelines.