510(k) · Cleared
ClearedFLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluoptics Sas (A Getinge Group Company} · QDG Parathyroid Autofluorescence Imaging Device
Cleared on Apr 17, 2025 as substantially equivalent to K233564 (Fluoptics Sas (A Getinge Group Company), 2023) after a 58-day review. Its family tree reaches back 3 generations to 2019.
- Decided
- Apr 17, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- QDG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K190891 (2019). No later device cites it as a predicate yet.
- Root · 3 generations backK190891 Fluobeam LXFluoptics · 2019
- 2 generations backK230898 FLUOBEAM® LX RedFluoptics Sas · 2023
- 1 generation backK233564 FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System…Fluoptics Sas (A Getinge Group Company) · 2023
- This deviceK250455 FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company} · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K190891 | Fluobeam LX | Fluoptics | 2019 | — |
| −2 | K230898 | FLUOBEAM® LX Red | Fluoptics Sas | 2023 | — |
| −1 | K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) | 2023 | — |
| 0 (this device) | K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics Sas (A Getinge Group Company} | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDG device
- #1 K253303 Dendrite Imaging Systemscore 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Summary page 5…8.4550; OWN/ 21 CFR 876.1500 Classification: Class II Predicate Device: Submitter Name: FLUOPTICS SAS Device Trade Name: FLUOBEAM LX (K233564) Device Common Name: Fluorescence imaging system Classification Name(s): Autofluorescence detection device for genera… | 2023 |
| † | K223020 | VS3-Iridium System (VS3-IR) | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QDG devicesQDG Parathyroid Autofluorescence Imaging Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QDG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QDG
Too few QDG 510(k)s in any year since 2007 to give a median.
Recalls per year · QDG
No recall names QDG since 2007.
Adverse event reports per year · QDG
No MAUDE report names QDG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FLUOBEAM LX and FLUOBEAM LM 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 LM 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…
Read the full statement (237 words)
FLUOBEAM LX and FLUOBEAM LM 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 LM 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 LM 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 LM 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.
Upon interstitial administration and use of ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250455: FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026