# K233564: FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

- Pathway: 510(k) (Special)
- Applicant: Fluoptics Sas (A Getinge Group Company)
- Decided: Dec 15, 2023 after 39 days
- Product code: QDG (Parathyroid Autofluorescence Imaging Device)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190891 (2019). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190891: Fluobeam LX, Fluoptics (2019) Summary page 5.
- K230898: FLUOBEAM® LX Red, Fluoptics Sas (2023) Summary page 5.

## Most influential descendants
- K250455: FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (2025), 0 descendants of its own

## Indications for use
FLUOBEAM® LX and FLUOBEAM® LX Red are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM® LX and FLUOBEAM® LX Red are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries. The FLUOBEAM® LX and FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX and FLUOBEAM® LX Red devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

Source page: https://510kreport.com/device/K233564
Methodology: https://510kreport.com/methodology