LHN · System, Radiation Therapy, Charged-Particle, Medical
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | LHN |
|---|---|
| Device Name | System, Radiation Therapy, Charged-Particle, Medical |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Cleared Devices (90)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Mar 25, 2026 | SESE |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | Sep 12, 2025 | SESE |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | Jun 27, 2025 | SESE |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | May 12, 2025 | SESE |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Jan 12, 2024 | SESE |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | Oct 6, 2023 | SESE |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | Mar 20, 2023 | SESE |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Dec 15, 2022 | SESE |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | Dec 1, 2022 | SESE |
| K201798 | myQA iON | Iba Dosimetry GmbH | Jul 17, 2020 | SESE |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | Jul 13, 2020 | SESE |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | Apr 8, 2020 | SESE |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | Jan 23, 2020 | SESE |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | Sep 27, 2019 | SESE |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | Sep 13, 2019 | SESE |
| K181498 | X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC | Dec 10, 2018 | SESE |
| K181789 | VeriSuite | Medcom GmbH | Sep 21, 2018 | SESE |
| K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works | Aug 15, 2018 | SESE |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems | Dec 27, 2017 | SESE |
| K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | Dec 26, 2017 | SESE |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. | Aug 17, 2017 | SESE |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | Apr 5, 2017 | SESE |
| K162246 | ProNova SC360 Proton Therapy System | Pronova Solutions, LLC | Dec 8, 2016 | SESE |
| K160612 | Sumitomo Proton Therapy System | Sumitomo Heavy Industries, Ltd. | Aug 17, 2016 | SESE |
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | Ion Beam Application S.A. | Aug 9, 2016 | SESE |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Hitachi , Ltd. | Jul 13, 2016 | SESE |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | Apr 22, 2016 | SESE |
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | Apr 21, 2016 | SESE |
| K160063 | McLaren Proton Therapy System | Mclaren Health Care Corporation | Feb 25, 2016 | SESE |
| K152592 | PROBEAT-V | Hitachi, Ltd., Health Care Company | Nov 2, 2015 | SESE |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | Oct 2, 2015 | SESE |
| K151132 | PROBEAT-V | Hitachi, Ltd., Health Care Company | Jun 1, 2015 | SESE |
| K132919 | GANTRY BEAM LINE | Ion Beam Applications S.A. | Jul 10, 2014 | SESE |
| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | Medcom GmbH | Apr 3, 2014 | SESE |
| K134052 | RADIANCE 330 PROTON THERAPY SYSTEM | Protom International, Inc. | Mar 14, 2014 | SESE |
| K133191 | PROBEAM PROTON THERAPY SYSTEM | Varian Medical Systems | Jan 10, 2014 | SESE |
| K132847 | I2C | Ion Beam Applications S.A. | Nov 20, 2013 | SESE |
| K130426 | SUMITOMO PROTON THERAPY SYSTEM | Sumitomo Heavy Industries, Ltd. | Nov 19, 2013 | SESE |
| K124002 | VERIFICATION CONSOLE | Varian Medical Systems | Feb 21, 2013 | SESE |
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | Mevion Medical Systems | Jun 4, 2012 | SESE |
| K112969 | AIR-BAG SYSTEM | Niigata Mechatronics Co., Ltd. | Mar 14, 2012 | SESE |
| K112981 | SUN 125C IONIZATION CHAMBER | Sun Nuclear Corp. | Jan 25, 2012 | SESE |
| K112768 | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | Nov 18, 2011 | SESE |
| K101294 | PT2 VARIAN PROTON THERAPY SYSTEM | Varian Medical Systems, Oncology Systems | Dec 27, 2010 | SESE |
| K102373 | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING | Calypso Medical Technologies, Inc. | Sep 30, 2010 | SESE |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | Ion Beam Applications S.A. | Aug 6, 2010 | SESE |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | Ion Beam Applications S.A. | Jul 21, 2010 | SESE |
| K093250 | PROTON THERAPY MULTILEAF COLLIMATOR | Varian Medical Systems | Dec 24, 2009 | SESE |
| K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | Ion Beam Applications S.A. | Dec 22, 2009 | SESE |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | Medcom GmbH | Sep 18, 2009 | SESE |
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM | Ion Beam Applications S.A. | Aug 11, 2009 | SESE |
| K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | Apr 15, 2009 | SESE |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | Ion Beam Applications S.A. | Dec 12, 2008 | SESE |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Computerized Medical Systems, Inc. | Aug 7, 2008 | SESE |
| K080886 | IPLAN RT IMAGE | Brainlab AG | Jun 24, 2008 | SESE |
| K073059 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM | Hitachi, Ltd., Power Systems Group | Dec 10, 2007 | SESE |
| K071399 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 | Sicel Technologies, Inc. | Jun 20, 2007 | SESE |
| K062891 | PROTON THERAPY SYSTEM | Indiana University Cyclotron Facility | Dec 14, 2006 | SESE |
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | Jul 28, 2006 | SESE |
| K061051 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER | Sicel Technologies, Inc. | Jun 13, 2006 | SESE |
| K061152 | MUCHECK V7.0 | Oncology Data Systems, Inc. | May 10, 2006 | SESE |
| K060834 | PROBEAT WITH MGCS | Hitachi , Ltd. | Apr 19, 2006 | SESE |
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | Ion Beam Applications S.A. | Apr 11, 2006 | SESE |
| K052118 | DOSE VERIFICATION SYSTEM | Sicel Technologies, Inc. | Apr 3, 2006 | SESE |
| K053280 | PROBEAT | Hitachi, Ltd., Power Systems Group | Mar 9, 2006 | SESE |
| K053641 | IBA PROTON THERAPY SYSTEM-PROTEUS 235 | Ion Beam Applications S.A. | Jan 24, 2006 | SESE |
| K032511 | INTUITION IMAGE | Brainlab AG | Jan 21, 2004 | SESE |
| K032886 | DIAMOND SETUP 2000 | K&S Assoc., Inc. | Jan 9, 2004 | SESE |
| K031385 | ANZAI AZ-733 RESPIRATORY GATING SYSTEM | Anzai Medical Co., Ltd. | Nov 10, 2003 | SESE |
| K983332 | NORTHEAST PROTON THERAPY CENTER | Massachusetts General Hospital | Jul 20, 2001 | SESE |
| K983024 | PROTON THERAPY SYSTEM | Ion Beam Applications S.A. | Jul 12, 2001 | SESE |
| K002194 | TREATVISION | Varian Medical Systems, Inc. | Aug 18, 2000 | SESE |
| K992414 | PROTON BEAM THERAPY SYSTEM (PBTS) | Optivus Technology, Inc. | Jul 21, 2000 | SESE |
| K983660 | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) | Brainlab, Inc. | Jul 14, 1999 | SESE |
| K983629 | RPM RESPIRATORY GATING SYSTEM | Varian Medical Systems, Inc. | Jun 8, 1999 | SESE |
| K982952 | IMFAST | Siemens Medical Solutions USA, Inc. | Mar 5, 1999 | SESE |
| K983342 | MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE | Philips Medical Systems (Cleveland), Inc. | Dec 21, 1998 | SESE |
| K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | Victoreen, Inc. | Nov 19, 1998 | SESE |
| K981112 | MOBETRON | Intraop Medical, Inc. | Jul 24, 1998 | SESE |
| K981358 | ARTOSCAN S | Biosound Esaote, Inc. | Jul 13, 1998 | SESE |
| K981115 | RADIO-PLAST | Smith & Nephew, Inc. | Jun 25, 1998 | SESE |
| K973960 | MODEL 37-185 | Victoreen, Inc. | Jan 14, 1998 | SESE |
| K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER | Ptw-New York Corp. | Sep 10, 1997 | SESE |
| K972211 | MULTIDOS, QC6PLUS | Ptw-New York Corp. | Sep 10, 1997 | SESE |
| K953391 | TREATMENT MANAGEMENT SYSTEM | Siemens Medical Solutions USA, Inc. | Mar 7, 1996 | SESE |
| K891261 | INTRAOPERATIVE RADIATION THERAPY DEVICES | General Electric Co. | Apr 26, 1989 | SESE |
| K860606 | RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM | Bionix Corp. | Mar 20, 1986 | SESE |
| K853964 | COMPUTERIZED RADIATION TREATMENT PLANNING SYS | Computerized Medical Systems, Inc. | Dec 5, 1985 | SESE |
| K851301 | TARGET CAT#B7850AA & B7850AB & B7850B | General Electric Co. | Sep 20, 1985 | SESE |
| K852907 | SIEMENS MEVATRON ME | Siemens Medical Laboratories, Inc. | Sep 19, 1985 | SESE |
Top Applicants
- Ion Beam Applications S.A. — 13 clearances
- Varian Medical Systems, Inc. — 4 clearances
- Hitachi, Ltd., Health Care Company — 4 clearances
- Hitachi , Ltd. — 4 clearances
- Varian Medical Systems — 3 clearances
