510(k) Report

Devices descending from K053280

26 later devices reach Probeat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130426Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20131—
+1K120676S-250 Proton Beam Radiation Therapy SystemMevion Medical Systems2012512
+1K073059Probeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group2007161
+1K060834Probeat with MGCSHitachi, Ltd.200617—
+2K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems201725
+2K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd.20160—
+2K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.201647
+2K152592Probeat-VHitachi, Ltd., Health Care Company201571
+2K151132Probeat-VHitachi, Ltd., Health Care Company2015101
+2K134052Radiance 330 Proton Therapy SystemProtom International, Inc.20144—
+3K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20251—
+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—
+3K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus…Ion Beam Applications S.A.2017011
+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—
+4K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.20260—
+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