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 |