FDA.reportPublic FDA data

Proton therapy system

Definition
An assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.
GUDID devices
45
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00858991006194ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KG3.02026-04-29
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.S250-FIT2026-04-30
00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.S250-FIT-VIS2026-05-04
04560333350334PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT2026-04-01
04560333350341PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT WITH MGCS2026-04-01
04560333350358PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT WITH DISCRETE SPOT SCANNING SYSTEM2026-04-01
04560333350365PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-V2026-04-01
04560333350372PROBEATHITACHI HIGH-TECH CORPORATIONEXTENDED RANGE SHIFTER FOR PROBEAT-V2026-04-01
04560333350389PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-V2026-04-01
04560333350396PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-V AND ACCESSORIES2026-04-01
04560333350402PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-V PROTON BEAM THERAPY SYSTEM WITH X-RAY LI2026-04-01
04560333350419PROBEATHITACHI HIGH-TECH CORPORATIONReal Time Image Gating System for Proton Beam Ther2026-04-01
04560333350426PROBEATHITACHI HIGH-TECH CORPORATIONMini Ridge Filter and auxiliary functions for PROB2026-04-01
04560333350433PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-CR2026-04-01
04560333350440PROBEATHITACHI HIGH-TECH CORPORATIONPROBEAT-FR2026-04-01
04560333350457PROBEATHITACHI HIGH-TECH CORPORATIONSmall Field Applicator2026-04-01
04560333350464PROBEATHITACHI HIGH-TECH CORPORATIONSmall Field Applicator2026-04-01
04560333350280PROBEATHITACHI, LTD.Small Field Applicator for PROBEAT-V2026-01-20
00858991006132ProBeam Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KG4.3 MR62025-04-29
00858991006149ProBeam Proton Therapy System - Fixed Beam RoomVarian Medical Systems Particle Therapy GmbH & Co. KG4.3 MR62025-04-29
04560333350204PROBEATHITACHI, LTD.PROBEAT-FR2024-01-19
04560333350211PROBEATHITACHI, LTD.Mini Ridge Filter and auxiliary functions for PROB2023-12-20
04560333350228PROBEATHITACHI, LTD.Real Time Image Gating System for Proton Beam Ther2023-12-20
00858991006088ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KG2.02023-10-25
04560333350198PROBEATHITACHI, LTD.Small Field Applicator for PROBEAT-V2023-10-02
00858991006071ProBeam 360 Proton Therapy System - Rotaiting GantryVarian Medical Systems Particle Therapy GmbH & Co. KG1.02022-12-06
00858991006064ProBeam® Proton Therapy System - Fixed Beam RoomVarian Medical Systems Particle Therapy GmbH & Co. KG4.32021-09-30
00858991006057ProBeam® Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KG4.32021-07-01
05404013801138 IBA Proton Therapy System – Proteus 235Ion Beam Applications SAProteus PLUS/Proteus ONE2021-02-28
00861552000418Radiance 330PROTOM INTERNATIONAL HOLDING CORPORATION10012020-03-24
04560333350006PROBEATHITACHI, LTD.PROBEAT-CR2019-09-24
00858991006026ProBeam® Fixed Beam Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KG3.52019-09-12
00858991006033ProBeam® Rotating Gantry Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KG3.52019-09-12
00858991006040ProBeam® Rotating Gantry Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KG4.22019-09-12
05404013810901Proteus 235Ion Beam Applications SAProteus PLUS2018-01-31
05404013813308Proteus 235Ion Beam Applications SAProteus PLUS2017-10-23
05404013814015Proteus 235Ion Beam Applications SAProteus PLUS2018-08-03
05404013820504Proteus 235Ion Beam Applications SAProteus ONE2017-09-22
05404013821303Proteus 235Ion Beam Applications SAProteus ONE2017-09-28
00858991006002ProBeam Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KG3.02016-09-21
00858991006019ProBeam Proton Therapy SystemVarian Medical Systems Particle Therapy GmbH & Co. KG3.02016-09-21
00863274000301PRONOVA SC360PRONOVA SOLUTIONS, LLCR1.02018-02-19
00863274000318ProNova SC360PRONOVA SOLUTIONS, LLCR1.12018-10-09
00864366000100Mevion Medical SystemsMEVION MEDICAL SYSTEMS, INC.S2502016-05-06
00864366000124MEVION S250iMEVION MEDICAL SYSTEMS, INC.S250i2018-02-05