510(k) Report

Devices descending from K190891

4 later devices reach Fluobeam LX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253303Dendrite Imaging SystemDendrite Imaging, Inc.20250—
+1K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)20231—
+1K230898FLUOBEAM® LX RedFluoptics Sas20232—
+2K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}20250—