FLUOBEAM® LX Red
K-Number: K230898 · 2023-07-28
ApplicantFluoptics Sas
Decision Date2023-07-28
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FLUOBEAM® LX Red is a medical device manufactured by Fluoptics Sas. It received FDA 510(k) clearance on 2023-07-28 under approval number K230898. 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 Red?
FLUOBEAM® LX Red is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Fluoptics Sas. The 510(k) number is K230898.
When was FLUOBEAM® LX Red approved by the FDA?
FLUOBEAM® LX Red received FDA 510(k) clearance on 2023-07-28, under approval number K230898.
What company makes FLUOBEAM® LX Red?
FLUOBEAM® LX Red is manufactured by Fluoptics Sas.
What is the FDA product code for FLUOBEAM® LX Red?
The FDA product code for FLUOBEAM® LX Red is QDG.
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K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)
K253303Dendrite Imaging SystemDendrite Imaging, Inc.
K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}
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.