510(k) Report

Devices descending from K160518

5 later devices reach LEONI ORION System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231612Eve Patient Positioner SystemLeo Cancer Care20240—
+1K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.20222—
+1K182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc.20190—
+2K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.20260—
+2K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.20231—