System, Radiation Therapy, Charged-particle, Medical
Product Code: LHN
Radiology Radioisotope Therapy Devices
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Code of Federal Regulations: 892.5050
| Radiation Type | Ionizing |
| Radition Safety | None |
| Annual Reports | No |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. |
| K201798 | MyQA ION | IBA Dosimetry GmbH |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV |
| K191821 | Blue Phantom PT | IBA Dosimetry GmbH |
| K191801 | PROBEAT-CR | Hitachi Ltd. |
| K191521 | Radiance 330 Proton Beam Therapy System | ProTom International Holding Corporation |
| K181789 | VeriSuite | MedCom GmbH |
| K181676 | Mini Ridge Filter And Auxiliary Functions For PROBEAT-V | Hitachi Ltd. Healthcare Hitachi Works |
| K181498 | X-ray Imaging System For The McLaren Proton Treatment System | EhmetDx, LLC |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | Mevion Medical Systems |
| K171049 | Real Time Image Gating System For Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. |
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. |
| K162246 | ProNova SC360 Proton Therapy System | ProNova Solutions, LLC |
| K161163 | PROBEAT-V Proton Beam Therapy System With X-ray Limiting Accessory | HITACHI, LTD. |
| 00864366000124 | System, Radiation Therapy, Charged-Particle, Medical |
| 00864366000100 | System, Radiation Therapy, Charged-Particle, Medical |
| 00863274000318 | System, Radiation Therapy, Charged-Particle, Medical |
| 00863274000301 | System, Radiation Therapy, Charged-Particle, Medical |
| 00861396000308 | System, Radiation Therapy, Charged-Particle, Medical |
| 00858991006019 | System, radiation therapy, charged-particle, medical |
| 00858991006002 | System, radiation therapy, charged-particle, medical |
| 05404013833313 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013830923 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013830916 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013830909 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013830626 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013830534 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013821303 | System, Radiation Therapy, Charged-Particle, Medical |
| 05404013820504 | System, Radiation Therapy, Charged-Particle, Medical |
| EXTERNAL BEAM RADIATION | UNK | 2019-06-11 |
| HYBEAT | HITACHI, LTD., HEALTCARE HITACHI WORKS | 2019-04-15 |
| PROTON RADIATION THERAPY | UNK | 2019-03-27 |
| PROTEUSONE | IBA (ION BEAM APPLICATIONS) | 2018-12-21 |
| ADAPTINSIGHT | IBA (ION BEAM APPLICATIONS) | 2018-11-30 |
| PROTEUSONE | IBA (ION BEAM APPLICATIONS) | 2018-11-23 |
| WHOLE BRAIN RADIATION THERAPY 37.5 GY IN 15 FRACTIONS | | 2018-06-29 |
| PROTEUSPLUS | IBA (ION BEAM APPLICATIONS) | 2018-05-22 |
| PROTEUSPLUS | IBA (ION BEAM APPLICATIONS) | 2018-05-04 |
| PROTEUSPLUS | IBA (ION BEAM APPLICATIONS) | 2018-05-03 |
| PROTEUSPLUS | IBA (ION BEAM APPLICATIONS) | 2017-10-19 |
| PROTEUSPLUS | IBA (ION BEAM APPLICATIONS) | 2017-09-28 |
| RADIATION THERAPY | UNK | 2017-08-21 |
| PROTEUSONE | ION BEAM APPLICATIONS | 2017-04-07 |
| PROBEAT | HITACHI, LTD., HEALTHCARE HITACHI WORKS | 2017-03-12 |
| PROBEAT-V | HITACHI, LTD., HEALTHCARE HITACHI WORKS | 2017-03-11 |
| G2SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL | HITACHI AMERICA, LTD., HEALTHCARE DIVISION | 2017-02-06 |
| MEVION S250 | MEVION MEDICAL SYSTEMS, INC. | 2017-01-13 |
| MEVION S250 | | 2016-12-23 |
| PROBEAT | HITACHI | 2015-11-09 |
| PROBEAT | HITACHI, LTD, POWER SYSTEMS COMPANY, HITACHI WORKS | 2015-04-22 |
| PROTON THERAPY | OPTIVUS PROTON THERAPY | 2014-12-26 |
| PROBEAM PROTON THERAPY SYSTEM | | 2014-05-02 |
| VERISUITE 1.8 | MEDCOM GMBH | 2014-04-29 |
| AURORA 1.5T BREAST MRI | AURORA IMAGING TECHNOLOGY, INC. | 2014-01-31 |
| PROTON THERAPY SYSTEM | IBA | 2014-01-23 |
| SYSTEM EQUIPMENT | SIEMENS | 2013-03-13 |
| PROTON THERAPY SYSTEM | INDIANA UNIVERSITY CYCLOTRON OPERATIONS | 2012-11-15 |
| RPM RESPIRATORY GATING SYSTEM | VARIAN MEDICAL SYSTEMS, INC. | 2011-02-03 |
| 4D INTEGRATED TREATMENT CONSOLE | VARIAN MEDICAL SYSTEMS | 2010-12-17 |
| BRAINLAB NOVALIS TX | FEIDKIRCHEN | 2010-12-01 |
| ON-BOARD IMAGER (OBI) | VARIAN MEDICAL SYSTEMS | 2010-01-14 |
| ON-BOARD IMAGER (OBI) | VARIAN MEDICAL SYSTEMS | 2009-12-16 |
| ON-BOARD IMAGER (OBI) | VARIAN MEDICAL SYSTEMS | 2009-12-08 |
| ON-BOARD IMAGER (OBI) | VARIAN MEDICAL SYSTEMS | 2009-10-23 |
| ON-BOARD IMAGER (OBI) | VARIAN MEDICAL SYSTEMS | 2009-09-23 |
| NALHN (CYCLOTRON) | INDIANA UNIVERSITY CYCLOTRON FACILITY | 2009-07-10 |
| MOBETRON | INTRAOP MEDICAL CORP. | 2008-06-23 |
| BODYFIX | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH | 2006-05-05 |
| ACQPLAN 5.0 | PHILIPS MEDICAL SYSTEMS | 2003-08-28 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORP. (MIAMI) | 2002-06-06 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORPORATION (MIAMI) | 2002-06-05 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORPORATION (MIAMI) | 2002-05-29 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORPORATION (MIAMI) | 2002-04-03 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORPORATION (MIAMI) | 2002-04-03 |
| MED-TEC | MED-TEC, INC. | 2002-03-13 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORPORATION (MIAMI) | 2002-03-11 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORP.(MIAMI) | 2002-03-08 |
| ** | INTRAOP MEDICAL, INC. | 2001-06-20 |
| IRT DELIVERY DEVICE WITH 10 SEED RIBBON | CORDIS CORP. (MIAMI) | 2001-05-04 |