FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
FLUOPTICS SAS (a Getinge Group Company}The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.
Intended Use
Provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures to visualize vessels, blood flow, tissue perfusion, parathyroid glands, lymphatic system, and tissues with specific dyes like ICG and pafolacianine.
Technology
The system uses a Class 1 infrared laser at 750nm to excite fluorescence in tissue, captured by a color CMOS sensor camera in the optical head. The video signal is digitized and processed by imaging software (FLUOSOFT LX or LM) to display and record fluorescent images in real time during surgery. It operates similarly to predicate and reference fluorescence imaging devices using near infrared dyes ICG and pafolacianine.
Performance
Bench testing demonstrated the device could image different concentrations of ICG and pafolacianine effectively, comparable to predicate and reference devices. Software validation and human factors studies supported the expanded indications for lymphatic system visualization and use with pafolacianine, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/18/2025
1 month - 2
FDA Approval
4/17/2025
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