510(k) Report

Devices descending from K053500

2 later devices reach Frameless Radiosurgery Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202050Cranial 4Pi ImmobilizationBrainlab AG20201—
+2K243142Cranial 4Pi ImmobilizationBrainlab AG20250—