| PROBEAT-CR (K260174) | Hitachi High-Tech Corp. | 2026-06-11 |
| ProBeam 360 Proton Therapy System v3.0 (K252815) | Varian Medical Systems, Inc. | 2026-04-23 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K253406) | Mevion Medical Systems, Inc. | 2026-03-25 |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (K250986) | Mevion Medical Systems, Inc. | 2025-09-12 |
| eMotus Respiratory Motion Management System (K243900) | Empnia, Inc. | 2025-06-27 |
| P-Cure Proton Therapy System (PPTS) (K242418) | P-Cure, Ltd. | 2025-05-12 |
| PROBEAT-FR (K232032) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 |
| ProBeam 360° Proton Therapy System v2.0 (Multiroom) (K231863) | Varian Medical Systems, Inc. | 2023-10-06 |
| P-Cure Proton Beam Therapy System (K221996) | P-Cure, Ltd. | 2023-03-20 |
| Small Field Applicator (K220883) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 |
| ProBeam 360° Proton Therapy System (K221791) | Varian Medical Systems, Inc. | 2022-12-01 |
| myQA iON (K201798) | Iba Dosimetry GmbH | 2020-07-17 |
| PROBEAT-CR (K201042) | Hitachi , Ltd. | 2020-07-13 |
| Orfit Aerial Couchtop (K200282) | Orfit Industries NV | 2020-04-08 |
| Blue Phantom PT (K191821) | Iba Dosimetry GmbH | 2020-01-23 |
| Radiance 330 Proton Beam Therapy System (K191521) | Protom International Holding Corporation | 2019-09-27 |
| PROBEAT-CR (K191801) | Hitachi , Ltd. | 2019-09-13 |
| X-ray Imaging System for the McLaren Proton Treatment System (K181498) | Ehmetdx, LLC | 2018-12-10 |
| VeriSuite (K181789) | Medcom GmbH | 2018-09-21 |
| Mini Ridge Filter and auxiliary functions for PROBEAT-V (K181676) | Hitachi Ltd. Healthcare Hitachi Works | 2018-08-15 |
| MEVION S250i Proton Beam Radiation Therapy Device (K172848) | Mevion Medical Systems | 2017-12-27 |
| Real Time Image Gating System for Proton Beam Therapy Systems (K171049) | Hitachi, Ltd. Healthcare | 2017-12-26 |
| IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (K163500) | Ion Beam Applications S.A. | 2017-08-17 |
| Anzai Respiratory Gating System (K170719) | Anzai Medical Co., Ltd. | 2017-04-05 |
| ProNova SC360 Proton Therapy System (K162246) | Pronova Solutions, LLC | 2016-12-08 |
| Sumitomo Proton Therapy System (K160612) | Sumitomo Heavy Industries, Ltd. | 2016-08-17 |
| Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) (K152224) | Ion Beam Application S.A. | 2016-08-09 |
| PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (K161163) | Hitachi , Ltd. | 2016-07-13 |
| Anzai Respiratory Gating System (K160432) | Anzai Medical Co., Ltd. | 2016-04-22 |
| PROBEAT-V and accessories (K153614) | Hitachi, Ltd., Health Care Company | 2016-04-21 |
| McLaren Proton Therapy System (K160063) | Mclaren Health Care Corporation | 2016-02-25 |
| PROBEAT-V (K152592) | Hitachi, Ltd., Health Care Company | 2015-11-02 |
| Extended Range Shifter for PROBEAT-V (K152207) | Hitachi, Ltd., Health Care Company | 2015-10-02 |
| PROBEAT-V (K151132) | Hitachi, Ltd., Health Care Company | 2015-06-01 |
| GANTRY BEAM LINE (K132919) | Ion Beam Applications S.A. | 2014-07-10 |
| VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE (K133914) | Medcom GmbH | 2014-04-03 |
| RADIANCE 330 PROTON THERAPY SYSTEM (K134052) | Protom International, Inc. | 2014-03-14 |
| PROBEAM PROTON THERAPY SYSTEM (K133191) | Varian Medical Systems | 2014-01-10 |
| I2C (K132847) | Ion Beam Applications S.A. | 2013-11-20 |
| SUMITOMO PROTON THERAPY SYSTEM (K130426) | Sumitomo Heavy Industries, Ltd. | 2013-11-19 |
| VERIFICATION CONSOLE (K124002) | Varian Medical Systems | 2013-02-21 |
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |
| AIR-BAG SYSTEM (K112969) | Niigata Mechatronics Co., Ltd. | 2012-03-14 |
| SUN 125C IONIZATION CHAMBER (K112981) | Sun Nuclear Corp. | 2012-01-25 |
| CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING (K112768) | Calypso Medical Technologies, Inc. | 2011-11-18 |
| PT2 VARIAN PROTON THERAPY SYSTEM (K101294) | Varian Medical Systems, Oncology Systems | 2010-12-27 |
| CALYPSO SYSTEM WITH DYNAMIC EDGE GATING (K102373) | Calypso Medical Technologies, Inc. | 2010-09-30 |
| MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K101508) | Ion Beam Applications S.A. | 2010-08-06 |
| IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 (K100766) | Ion Beam Applications S.A. | 2010-07-21 |
| PROTON THERAPY MULTILEAF COLLIMATOR (K093250) | Varian Medical Systems | 2009-12-24 |
| IBA PROTON THERAPY SYSTEM, PROTEUS 235 (K092796) | Ion Beam Applications S.A. | 2009-12-22 |
| VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 (K092653) | Medcom GmbH | 2009-09-18 |
| PROTEUS 235 PROTON THERAPY SYSTEM (K091629) | Ion Beam Applications S.A. | 2009-08-11 |
| IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K083058) | Ion Beam Applications S.A. | 2009-04-15 |
| IBA PROTON THERAPY SYSTEM- PROTEUS 235 (K082416) | Ion Beam Applications S.A. | 2008-12-12 |
| ATLAS-BASED AUTOSEGMENTATION (K080799) | Computerized Medical Systems, Inc. | 2008-08-07 |
| IPLAN RT IMAGE (K080886) | Brainlab AG | 2008-06-24 |
| PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM (K073059) | Hitachi, Ltd., Power Systems Group | 2007-12-10 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 (K071399) | Sicel Technologies, Inc. | 2007-06-20 |
| PROTON THERAPY SYSTEM (K062891) | Indiana University Cyclotron Facility | 2006-12-14 |
| IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K061913) | Ion Beam Applications S.A. | 2006-07-28 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER (K061051) | Sicel Technologies, Inc. | 2006-06-13 |
| MUCHECK V7.0 (K061152) | Oncology Data Systems, Inc. | 2006-05-10 |
| PROBEAT WITH MGCS (K060834) | Hitachi , Ltd. | 2006-04-19 |
| IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K060695) | Ion Beam Applications S.A. | 2006-04-11 |
| DOSE VERIFICATION SYSTEM (K052118) | Sicel Technologies, Inc. | 2006-04-03 |
| PROBEAT (K053280) | Hitachi, Ltd., Power Systems Group | 2006-03-09 |
| IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641) | Ion Beam Applications S.A. | 2006-01-24 |
| INTUITION IMAGE (K032511) | Brainlab AG | 2004-01-21 |
| DIAMOND SETUP 2000 (K032886) | K&S Assoc., Inc. | 2004-01-09 |
| ANZAI AZ-733 RESPIRATORY GATING SYSTEM (K031385) | Anzai Medical Co., Ltd. | 2003-11-10 |
| NORTHEAST PROTON THERAPY CENTER (K983332) | Massachusetts General Hospital | 2001-07-20 |
| PROTON THERAPY SYSTEM (K983024) | Ion Beam Applications S.A. | 2001-07-12 |
| TREATVISION (K002194) | Varian Medical Systems, Inc. | 2000-08-18 |
| PROTON BEAM THERAPY SYSTEM (PBTS) (K992414) | Optivus Technology, Inc. | 2000-07-21 |
| EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) (K983660) | Brainlab, Inc. | 1999-07-14 |
| RPM RESPIRATORY GATING SYSTEM (K983629) | Varian Medical Systems, Inc. | 1999-06-08 |
| IMFAST (K982952) | Siemens Medical Solutions USA, Inc. | 1999-03-05 |
| MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE (K983342) | Philips Medical Systems (Cleveland), Inc. | 1998-12-21 |
| MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER (K982937) | Victoreen, Inc. | 1998-11-19 |
| MOBETRON (K981112) | Intraop Medical, Inc. | 1998-07-24 |
| ARTOSCAN S (K981358) | Biosound Esaote, Inc. | 1998-07-13 |
| RADIO-PLAST (K981115) | Smith & Nephew, Inc. | 1998-06-25 |
| MODEL 37-185 (K973960) | Victoreen, Inc. | 1998-01-14 |
| MULTIDOS, QC6PLUS (K972211) | Ptw-New York Corp. | 1997-09-10 |
| 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER (K972212) | Ptw-New York Corp. | 1997-09-10 |
| TREATMENT MANAGEMENT SYSTEM (K953391) | Siemens Medical Solutions USA, Inc. | 1996-03-07 |
| INTRAOPERATIVE RADIATION THERAPY DEVICES (K891261) | General Electric Co. | 1989-04-26 |
| RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM (K860606) | Bionix Corp. | 1986-03-20 |
| COMPUTERIZED RADIATION TREATMENT PLANNING SYS (K853964) | Computerized Medical Systems, Inc. | 1985-12-05 |
| TARGET CAT#B7850AA & B7850AB & B7850B (K851301) | General Electric Co. | 1985-09-20 |
| SIEMENS MEVATRON ME (K852907) | Siemens Medical Laboratories, Inc. | 1985-09-19 |