Fluobeam LX
K-Number: K190891 · 2019-07-31
ApplicantFluoptics
Decision Date2019-07-31
Product CodeQDG
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Fluobeam LX is a medical device manufactured by Fluoptics. It received FDA 510(k) clearance on 2019-07-31 under approval number K190891. 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?
Fluobeam LX is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Fluoptics. The 510(k) number is K190891.
When was Fluobeam LX approved by the FDA?
Fluobeam LX received FDA 510(k) clearance on 2019-07-31, under approval number K190891.
What company makes Fluobeam LX?
Fluobeam LX is manufactured by Fluoptics.
What is the FDA product code for Fluobeam LX?
The FDA product code for Fluobeam LX is QDG.
Other Devices by Fluoptics
Related Devices (Code: QDG)
DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics
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.
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.