FDA 510(k) Applications for Medical Device Product Code "LHN"
(System, Radiation Therapy, Charged-Particle, Medical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K031385 | ANZAI MEDICAL CO, LTD. | ANZAI AZ-733 RESPIRATORY GATING SYSTEM | 11/10/2003 |
| K160432 | ANZAI MEDICAL CO, LTD. | Anzai Respiratory Gating System | 04/22/2016 |
| K170719 | Anzai Medical Co., Ltd. | Anzai Respiratory Gating System | 04/05/2017 |
| K981358 | BIOSOUND ESAOTE, INC. | ARTOSCAN S | 07/13/1998 |
| K080886 | BRAINLAB AG | IPLAN RT IMAGE | 06/24/2008 |
| K032511 | BRAINLAB, AG | INTUITION IMAGE | 01/21/2004 |
| K983660 | BRAINLAB, INC. | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) | 07/14/1999 |
| K102373 | CALYPSO MEDICAL TECHNOLOGIES INC | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING | 09/30/2010 |
| K112768 | CALYPSO MEDICAL TECHNOLOGIES INC | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING | 11/18/2011 |
| K080799 | COMPUTERIZED MEDICAL SYSTEMS, INC. | ATLAS-BASED AUTOSEGMENTATION | 08/07/2008 |
| K181498 | EhmetDx, LLC | X-ray Imaging System for the McLaren Proton Treatment System | 12/10/2018 |
| K201042 | Hitachi Ltd. | PROBEAT-CR | 07/13/2020 |
| K191801 | Hitachi Ltd. | PROBEAT-CR | 09/13/2019 |
| K181676 | Hitachi Ltd. Healthcare Hitachi Works | Mini Ridge Filter and auxiliary functions for PROBEAT-V | 08/15/2018 |
| K060834 | HITACHI, LTD. | PROBEAT WITH MGCS | 04/19/2006 |
| K161163 | HITACHI, LTD. | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | 07/13/2016 |
| K171049 | Hitachi, Ltd. Healthcare | Real Time Image Gating System for Proton Beam Therapy Systems | 12/26/2017 |
| K220883 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Small Field Applicator | 12/15/2022 |
| K153614 | HITACHI, LTD., HEALTH CARE COMPANY | PROBEAT-V and accessories | 04/21/2016 |
| K053280 | HITACHI, LTD., POWER SYSTEMS GROUP | PROBEAT | 03/09/2006 |
| K073059 | HITACHI, LTD., POWER SYSTEMS GROUP | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM | 12/10/2007 |
| K151132 | Hitachi, Ltd.,Health Care Company | PROBEAT-V | 06/01/2015 |
| K152592 | Hitachi, Ltd.,Health Care Company | PROBEAT-V | 11/02/2015 |
| K152207 | Hitachi,Ltd. , Health Care Company | Extended Range Shifter for PROBEAT-V | 10/02/2015 |
| K191821 | IBA Dosimetry GmbH | Blue Phantom PT | 01/23/2020 |
| K201798 | IBA Dosimetry GmbH | myQA iON | 07/17/2020 |
| K062891 | INDIANA UNIVERSITY CYCLOTRON FACILITY | PROTON THERAPY SYSTEM | 12/14/2006 |
| K981112 | INTRAOP MEDICAL, INC. | MOBETRON | 07/24/1998 |
| K152224 | ION BEAM APPLICATION S.A. | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) | 08/09/2016 |
| K132919 | ION BEAM APPLICATIONS S.A. | GANTRY BEAM LINE | 07/10/2014 |
| K132847 | ION BEAM APPLICATIONS S.A. | I2C | 11/20/2013 |
| K061913 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | 07/28/2006 |
| K083058 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | 04/15/2009 |
| K060695 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | 04/11/2006 |
| K082416 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | 12/12/2008 |
| K163500 | Ion Beam Applications S.A. | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | 08/17/2017 |
| K053641 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM-PROTEUS 235 | 01/24/2006 |
| K100766 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | 07/21/2010 |
| K092796 | ION BEAM APPLICATIONS S.A. | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | 12/22/2009 |
| K101508 | ION BEAM APPLICATIONS S.A. | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | 08/06/2010 |
| K091629 | ION BEAM APPLICATIONS S.A. | PROTEUS 235 PROTON THERAPY SYSTEM | 08/11/2009 |
| K983024 | ION BEAM APPLICATIONS S.A. | PROTON THERAPY SYSTEM | 07/12/2001 |
| K032886 | K&S ASSOC., INC. | DIAMOND SETUP 2000 | 01/09/2004 |
| K983332 | MASSACHUSETTS GENERAL HOSPITAL | NORTHEAST PROTON THERAPY CENTER | 07/20/2001 |
| K160063 | McLaren Health Care Corporation | McLaren Proton Therapy System | 02/25/2016 |
| K181789 | MedCom GmbH | VeriSuite | 09/21/2018 |
| K133914 | MEDCOM GMBH | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | 04/03/2014 |
| K092653 | MEDCOM GMBH | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | 09/18/2009 |
| K172848 | Mevion Medical Systems | MEVION S250i Proton Beam Radiation Therapy Device | 12/27/2017 |
| K120676 | MEVION MEDICAL SYSTEMS | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | 06/04/2012 |
| K112969 | NIIGATA MECHATRONICS CO., LTD. | AIR-BAG SYSTEM | 03/14/2012 |
| K061152 | ONCOLOGY DATA SYSTEMS, INC. | MUCHECK V7.0 | 05/10/2006 |
| K992414 | OPTIVUS TECHNOLOGY, INC. | PROTON BEAM THERAPY SYSTEM (PBTS) | 07/21/2000 |
| K200282 | Orfit Industries NV | Orfit Aerial Couchtop | 04/08/2020 |
| K221996 | P-Cure Ltd. | P-Cure Proton Beam Therapy System | 03/20/2023 |
| K983342 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE | 12/21/1998 |
| K162246 | ProNova Solutions, LLC | ProNova SC360 Proton Therapy System | 12/08/2016 |
| K191521 | ProTom International Holding Corporation | Radiance 330 Proton Beam Therapy System | 09/27/2019 |
| K134052 | ProTom International, Inc. | RADIANCE 330 PROTON THERAPY SYSTEM | 03/14/2014 |
| K972212 | PTW-NEW YORK CORP. | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER | 09/10/1997 |
| K972211 | PTW-NEW YORK CORP. | MULTIDOS, QC6PLUS | 09/10/1997 |
| K052118 | SICEL TECHNOLOGIES, INC. | DOSE VERIFICATION SYSTEM | 04/03/2006 |
| K071399 | SICEL TECHNOLOGIES, INC. | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 | 06/20/2007 |
| K061051 | SICEL TECHNOLOGIES, INC. | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER | 06/13/2006 |
| K982952 | SIEMENS MEDICAL SOLUTIONS USA, INC. | IMFAST | 03/05/1999 |
| K953391 | SIEMENS MEDICAL SOLUTIONS USA, INC. | TREATMENT MANAGEMENT SYSTEM | 03/07/1996 |
| K981115 | SMITH & NEPHEW, INC. | RADIO-PLAST | 06/25/1998 |
| K130426 | SUMITOMO HEAVY INDUSTRIES, LTD | SUMITOMO PROTON THERAPY SYSTEM | 11/19/2013 |
| K160612 | SUMITOMO HEAVY INDUSTRIES, LTD | Sumitomo Proton Therapy System | 08/17/2016 |
| K112981 | SUN NUCLEAR CORP. | SUN 125C IONIZATION CHAMBER | 01/25/2012 |
| K133191 | VARIAN MEDICAL SYSTEMS | PROBEAM PROTON THERAPY SYSTEM | 01/10/2014 |
| K093250 | VARIAN MEDICAL SYSTEMS | PROTON THERAPY MULTILEAF COLLIMATOR | 12/24/2009 |
| K124002 | VARIAN MEDICAL SYSTEMS | VERIFICATION CONSOLE | 02/21/2013 |
| K221791 | Varian Medical Systems, Inc. | ProBeam 360░ Proton Therapy System | 12/01/2022 |
| K231863 | Varian Medical Systems, Inc. | ProBeam 360░ Proton Therapy System v2.0 (Multiroom) | 10/06/2023 |
| K983629 | VARIAN MEDICAL SYSTEMS, INC. | RPM RESPIRATORY GATING SYSTEM | 06/08/1999 |
| K002194 | VARIAN MEDICAL SYSTEMS, INC. | TREATVISION | 08/18/2000 |
| K101294 | VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS | PT2 VARIAN PROTON THERAPY SYSTEM | 12/27/2010 |
| K973960 | VICTOREEN, INC. | MODEL 37-185 | 01/14/1998 |
| K982937 | VICTOREEN, INC. | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | 11/19/1998 |
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