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
K860606 BIONIX CORP. RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM 03/20/1986
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
K853964 COMPUTERIZED MEDICAL SYSTEMS, INC. COMPUTERIZED RADIATION TREATMENT PLANNING SYS 12/05/1985
K891261 GENERAL ELECTRIC CO. INTRAOPERATIVE RADIATION THERAPY DEVICES 04/26/1989
K851301 GENERAL ELECTRIC CO. TARGET CAT#B7850AA & B7850AB & B7850B 09/20/1985
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
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
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
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
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
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
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
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
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
K852907 SIEMENS MEDICAL LABORATORIES, INC. SIEMENS MEVATRON ME 09/19/1985
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
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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