KPQ · Class II · 21 CFR 892.5840

FDA Product Code KPQ: System, Simulation, Radiation Therapy

Leading manufacturers include Varian Assoc., Inc., Varian Medical Systems, Inc. and Nucletron Corporation.

70
Total
70
Cleared
109d
Avg days
1976
Since

FDA 510(k) Cleared System, Simulation, Radiation Therapy Devices (Product Code KPQ)

70 devices
1–24 of 70
Cleared Mar 14, 2014
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
K132944
Ge Hungary Kft
Radiology · 176d
Cleared Sep 04, 2013
ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
K132045
Ge Hungary Kft
Radiology · 64d
Cleared Aug 17, 2010
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
K101038
Acceletronics Digital Imaging, LLC
Radiology · 125d
Cleared Jun 15, 2009
ONCENTRA SIMULATION 2.3
K090706
Nucletron Corporation
Radiology · 90d
Cleared Dec 29, 2008
IKOENGELO, VERSION 2
K083591
Ikoetech, LLC
Radiology · 25d
Cleared Sep 14, 2007
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445
Nucletron Corp.
Radiology · 15d
Cleared Jun 05, 2006
IKOENGELO
K061006
Ikoetech, LLC
Radiology · 55d
Cleared Oct 24, 2005
SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM
K052361
Nucletron Corporation
Radiology · 56d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345
Ge Healthcare
Radiology · 19d
Cleared Feb 04, 2004
SIMULIX EVOLUTION
K033470
Nucletron Corporation
Radiology · 93d
Cleared Dec 30, 2003
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
K033339
Varian Medical Systems, Inc.
Radiology · 74d
Cleared Sep 25, 2003
EXOMIO, MODEL 2.0 SP1
K032550
Medcom GmbH
Radiology · 38d
Cleared Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 07, 2002
EXOMIO, MODEL 1.1
K022219
Medcom GmbH
Radiology · 90d
Cleared Jul 29, 2002
ADVANTAGE SIM 6.0
K021780
General Electric Medical Systems
Radiology · 60d
Cleared Nov 07, 2001
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531
Impac Medical Systems, Inc.
Radiology · 15d
Cleared Feb 16, 2000
SOMAVISION
K992751
Varian Assoc., Inc.
Radiology · 184d
Cleared Nov 04, 1998
HELAX-IMCON, VERSION 1.0
K982857
Helax AB
Radiology · 83d
Cleared Jan 22, 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848
Nucletron Corp.
Radiology · 106d
Cleared Aug 15, 1997
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839
Varian Medical Systems, Inc.
Radiology · 88d
Cleared May 05, 1997
SHADOWFORM
K964972
I.Z.I. Medical Products Corp.
Radiology · 144d
Cleared Jan 10, 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Nov 29, 1996
SIMVIEW 3000 CT OPTION
K953233
Siemens Medical Solutions USA, Inc.
Radiology · 508d
Cleared May 22, 1996
MODEL 555 010 XY CONVERSION(55010)
K960737
Systems Supply Services, Inc.
Radiology · 89d

About Product Code KPQ - Regulatory Context