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FDA 510(k)

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

K-Number: K233564 · 2023-12-15

ApplicantFluoptics Sas (A Getinge Group Company)
Decision Date2023-12-15
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) is a medical device manufactured by Fluoptics Sas (A Getinge Group Company). It received FDA 510(k) clearance on 2023-12-15 under approval number K233564. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Fluoptics Sas (A Getinge Group Company). The 510(k) number is K233564.

When was FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) approved by the FDA?

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) received FDA 510(k) clearance on 2023-12-15, under approval number K233564.

What company makes FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) is manufactured by Fluoptics Sas (A Getinge Group Company).

What is the FDA product code for FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)?

The FDA product code for FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) is QDG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: QDG)

DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics K190891Fluobeam LXFluoptics K230898FLUOBEAM® LX RedFluoptics Sas K253303Dendrite Imaging SystemDendrite Imaging, Inc. K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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