510(k) Report

Devices descending from K992414

27 later devices reach Proton Beam Therapy System (PBTS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K134052Radiance 330 Proton Therapy SystemProtom International, Inc.20144—
+1K053280ProbeatHitachi, Ltd., Power Systems Group200626—
+2K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation20192—
+2K160063McLaren Proton Therapy SystemMclaren Health Care Corporation20160—
+2K130426Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20131—
+2K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems2012512
+2K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group2007161
+2K060834Probeat with MGCSHitachi, Ltd.200617—
+3K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.20231—
+3K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems201725
+3K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20160—
+3K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.201647
+3K152592Probeat-VHitachi, Ltd., Health Care Company201571
+3K151132Probeat-VHitachi, Ltd., Health Care Company2015101
+4K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20251—
+4K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.20250—
+4K220883Small Field ApplicatorHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha20220—
+4K191801Probeat-CRHitachi, Ltd.201931
+4K181676Mini Ridge Filter and auxiliary functions for PROBEAT-VHitachi Ltd. Healthcare Hitachi Works20180—
+4K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A.2017011
+4K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi, Ltd.20160—
+4K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company20160—
+4K152207Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company20150—
+5K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20260—
+5K201042Probeat-CRHitachi, Ltd.202021
+6K260174Probeat-CRHitachi High-Tech Corp.20260—
+6K232032Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha202404