FDA 510(k) Applications for Medical Device Product Code "QDG"

FDA 510(k) Number Applicant Device Name Decision Date
DEN170092 Fluoptics Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System 11/02/2018
K190891 Fluoptics Fluobeam LX 07/31/2019
K230898 Fluoptics Sas FLUOBEAM« LX Red 07/28/2023
K233564 Fluoptics Sas (a Getinge Group Company) FLUOBEAM« LX Imaging System (FB-LX); FLUOBEAM« LX Red Imaging System (FB-LXR) 12/15/2023
K250455 FLUOPTICS SAS (a Getinge Group Company} FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) 04/17/2025


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