Product code LHN
- Device name
- System, Radiation Therapy, Charged-Particle, Medical
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026-04-23 |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026-03-25 |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025-09-12 |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | 2025-06-27 |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025-05-12 |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023-10-06 |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023-03-20 |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022-12-01 |
| K201798 | myQA iON | Iba Dosimetry GmbH | 2020-07-17 |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | 2020-07-13 |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | 2020-04-08 |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | 2020-01-23 |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | 2019-09-27 |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | 2019-09-13 |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | 2018-12-10 |
| K181789 | VeriSuite | Medcom GmbH | 2018-09-21 |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | 2017-12-27 |
| K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | 2017-12-26 |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. | 2017-08-17 |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2017-04-05 |
| K162246 | ProNova SC360 Proton Therapy System | Pronova Solutions, LLC | 2016-12-08 |
| K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | 2016-08-17 |
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | 2016-08-09 |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Hitachi , Ltd. | 2016-07-13 |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2016-04-22 |
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | 2016-04-21 |
| K160063 | McLaren Proton Therapy System | Mclaren Health Care Corporation | 2016-02-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EPTWTN310220 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-15 |
| EPTWTW310220 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-15 |
| EPTWTM310220 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-15 |
| EPTWTM310240 | Semiflex | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| EPTWTM310250 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| EPTWTN310240 | Semiflex | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| EPTWTN310250 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| EPTWTW310240 | Semiflex | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| EPTWTW310250 | PinPoint | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 2026-04-14 |
| 10841962111246 | Slate AirShuttle™ | Qfix | 2021-09-28 |
| 10841962111239 | AirDrive Trolley™ | Qfix | 2021-09-28 |
| 10841962111123 | ZiFix Traverse™ | Qfix | 2021-03-23 |
| 10841962110775 | SRS MR Adapter | Qfix | 2020-03-04 |
| 10841962110966 | Alta™ | Qfix | 2020-03-04 |
| 10841962110973 | InfinityLock™ | Qfix | 2020-03-04 |
| 10841962110980 | InfinityLock™ | Qfix | 2020-03-04 |
| 10841962110928 | Encompass™ SRS Fibreplast™ Anterior Mask | Qfix | 2018-12-10 |
| 10841962110768 | SRS Adapter | Qfix | 2018-10-09 |
| 10841962110706 | Symphony™ | Qfix | 2018-04-18 |
| 10841962110713 | Symphony™ | Qfix | 2018-04-18 |
| 10841962110508 | ZiFix™ | Qfix | 2017-07-17 |
| 10841962110447 | Symphony™ BoS™ | Qfix | 2017-03-16 |
| 10841962109540 | Symphony™ | Qfix | 2016-12-22 |
| 10841962109564 | Symphony™ | Qfix | 2016-12-22 |
| 10841962109489 | Encompass™ | Qfix | 2016-09-14 |
| 10841962109502 | Encompass™ | Qfix | 2016-09-14 |
| 10841962109496 | Encompass™ | Qfix | 2016-09-14 |
| 10841962109533 | Symphony™ | Qfix | 2016-09-14 |
| 10841962109526 | Encompass™ SRS Fibreplast™ System | Qfix | 2016-09-14 |
| 10841962109519 | Encompass™ SRS Fibreplast™ System | Qfix | 2016-09-14 |