510(k) Report

Devices descending from K134052

4 later devices reach Radiance 330 Proton Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation20192—
+1K160063McLaren Proton Therapy SystemMclaren Health Care Corporation20160—
+2K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.20231—
+3K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.20250—