510(k) Report

Devices descending from K210450

4 later devices reach BBX-PET Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250170PharosBrightonix Imaging20250—
+1K241751NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF SeatPositrigo AG20240—
+1K240827SET-5002Shimadzu Corporation Medical Systems Division20240—
+1K232569CaremibrainGeneral Equipment For Medical Imaging, S.A.20230—