510(k) Report

Devices descending from K970647

7 later devices reach Our Rotating Gamma System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190844Akesis GalaxyAkesis, Inc.20193—
+1K060314Rotating Gamma System. Gamma Art-6000American Radiosurgery, Inc.20062—
+2K200050Akesis Galaxy RTxAkesis, Inc.20202—
+2K172706GammaPod - Model AXcision Medical Systems, LLC201711
+3K203250TaiChiCOur United Corporation20210—
+3K203146Akesis Galaxy RTiAkesis, Inc.20210—
+3K180571GammaPodXcision Medical Systems, LLC201802