Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

K-Number: K250455 · 2025-04-17

ApplicantFluoptics Sas (A Getinge Group Company}
Decision Date2025-04-17
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is a medical device manufactured by Fluoptics Sas (A Getinge Group Company}. It received FDA 510(k) clearance on 2025-04-17 under approval number K250455. 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 (FBLX); FLUOBEAM LM Imaging System (FBLM)?

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Fluoptics Sas (A Getinge Group Company}. The 510(k) number is K250455.

When was FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) approved by the FDA?

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) received FDA 510(k) clearance on 2025-04-17, under approval number K250455.

What company makes FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)?

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is manufactured by Fluoptics Sas (A Getinge Group Company}.

What is the FDA product code for FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)?

The FDA product code for FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) is QDG.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

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 K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company) K230898FLUOBEAM® LX RedFluoptics Sas K253303Dendrite Imaging SystemDendrite Imaging, Inc.

Official Source

View on FDA Database →

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

↑