510(k) Report

Devices descending from K872369

47 later devices reach Loma Linda Univ. Proton Beam Therapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems2012512
+1K083058Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A.20091—
+1K082416Iba Proton Therapy System- Proteus 235Ion Beam Applications S.A.2008173
+1K062891Proton Therapy SystemIndiana University Cyclotron Facility20066—
+1K061913Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A.200661
+1K053641Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A.200625—
+1K983332Northeast Proton Therapy CenterMassachusetts General Hospital20018—
+1K983024Proton Therapy SystemIon Beam Applications S.A.200134—
+1K992414Proton Beam Therapy System (PBTS)Optivus Technology, Inc.200027—
+2K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems201725
+2K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC20160—
+2K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.201647
+2K134052Radiance 330 Proton Therapy SystemProtom International, Inc.20144—
+2K130426Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20131—
+2K124002Verification ConsoleVarian Medical Systems20130—
+2K101294PT2 Varian Proton Therapy SystemVarian Medical Systems, Oncology Systems201010—
+2K101508Modification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A.201066
+2K100766Iba Proton Therapy System, Model Proteus 235Ion Beam Applications S.A.20100—
+2K092796Iba Proton Therapy System, Proteus 235Ion Beam Applications S.A.20090—
+2K060695Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A.2006242
+2K053280ProbeatHitachi, Ltd., Power Systems Group200626—
+3K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20251—
+3K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation20192—
+3K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A.2017011
+3K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20160—
+3K160063McLaren Proton Therapy SystemMclaren Health Care Corporation20160—
+3K132919Gantry Beam LineIon Beam Applications S.A.201452
+3K133191Probeam Proton Therapy SystemVarian Medical Systems201431
+3K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group2007161
+3K060834Probeat with MGCSHitachi, Ltd.200617—
+4K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20260—
+4K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.20231—
+4K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.20222—
+4K152592Probeat-VHitachi, Ltd., Health Care Company201571
+4K151132Probeat-VHitachi, Ltd., Health Care Company2015101
+5K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.20260—
+5K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.20250—
+5K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.20231—
+5K220883Small Field ApplicatorHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha20220—
+5K191801Probeat-CRHitachi, Ltd.201931
+5K181676Mini Ridge Filter and auxiliary functions for PROBEAT-VHitachi Ltd. Healthcare Hitachi Works20180—
+5K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi, Ltd.20160—
+5K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company20160—
+5K152207Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company20150—
+6K201042Probeat-CRHitachi, Ltd.202021
+7K260174Probeat-CRHitachi High-Tech Corp.20260—
+7K232032Probeat-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha202404