510(k) Report

Devices descending from K060834

17 later devices reach Probeat with MGCS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group2007161
+2K152592Probeat-VHitachi, Ltd., Health Care Company201571
+2K151132Probeat-VHitachi, Ltd., Health Care Company2015101
+2K134052Radiance 330 Proton Therapy SystemProtom International, Inc.20144—
+3K220883Small Field ApplicatorHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha20220—
+3K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation20192—
+3K191801Probeat-CRHitachi, Ltd.201931
+3K181676Mini Ridge Filter and auxiliary functions for PROBEAT-VHitachi Ltd. Healthcare Hitachi Works20180—
+3K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi, Ltd.20160—
+3K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company20160—
+3K160063McLaren Proton Therapy SystemMclaren Health Care Corporation20160—
+3K152207Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company20150—
+4K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.20231—
+4K201042Probeat-CRHitachi, Ltd.202021
+5K260174Probeat-CRHitachi High-Tech Corp.20260—
+5K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.20250—
+5K232032Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha202404