510(k) Report

Devices descending from K230898

2 later devices reach FLUOBEAM® LX Red through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)20231—
+2K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}20250—