FDA 510(k) Applications for Medical Device Product Code "KPQ"
(System, Simulation, Radiation Therapy)

FDA 510(k) Number Applicant Device Name Decision Date
K101038 ACCELETRONICS DIGITAL IMAGING, LLC. RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER 08/17/2010
K052345 GE HEALTHCARE ADVANTAGE SIM MD 09/14/2005
K132944 GE HUNGARY KFT ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION 03/14/2014
K132045 GE HUNGARY KFT ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS 09/04/2013
K021780 GENERAL ELECTRIC MEDICAL SYSTEMS ADVANTAGE SIM 6.0 07/29/2002
K982857 HELAX AB HELAX-IMCON, VERSION 1.0 11/04/1998
K964972 I.Z.I. MEDICAL PRODUCTS CORP. SHADOWFORM 05/05/1997
K061006 IKOETECH, LLC. IKOENGELO 06/05/2006
K083591 IKOETECH, LLC. IKOENGELO, VERSION 2 12/29/2008
K013531 IMPAC MEDICAL SYSTEMS, INC. QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 11/07/2001
K022219 MEDCOM GMBH EXOMIO, MODEL 1.1 10/07/2002
K032550 MEDCOM GMBH EXOMIO, MODEL 2.0 SP1 09/25/2003
K973848 NUCLETRON CORP. IBU, INTEGRATED BRACHY THERAPY UNIT 01/22/1998
K072445 NUCLETRON CORP. INTEGRATED BRACHYTHERAPY UNIT - DIGITAL 09/14/2007
K090706 NUCLETRON CORPORATION ONCENTRA SIMULATION 2.3 06/15/2009
K033470 NUCLETRON CORPORATION SIMULIX EVOLUTION 02/04/2004
K052361 NUCLETRON CORPORATION SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM 10/24/2005
K953233 SIEMENS MEDICAL SOLUTIONS USA, INC. SIMVIEW 3000 CT OPTION 11/29/1996
K960737 SYSTEMS SUPPLY SERVICES, INC. MODEL 555 010 XY CONVERSION(55010) 05/22/1996
K992751 VARIAN ASSOC., INC. SOMAVISION 02/16/2000
K023052 VARIAN MEDICAL SYSTEMS, INC. ACUITY RADIATION THERAPY SIMULATOR 10/11/2002
K033339 VARIAN MEDICAL SYSTEMS, INC. ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY 12/30/2003
K971839 VARIAN MEDICAL SYSTEMS, INC. VARIAN RADIATION THERAPY IMAGING SYSTEM 08/15/1997
K964138 VARIAN MEDICAL SYSTEMS, INC. VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE 01/10/1997


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