510(k) Report

Devices descending from K060314

2 later devices reach Rotating Gamma System. Gamma Art-6000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172706GammaPod - Model AXcision Medical Systems, LLC201711
+2K180571GammaPodXcision Medical Systems, LLC201802