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 Jun 15, 2009
ONCENTRA SIMULATION 2.3
K090706
Nucletron Corporation
Radiology · 90d
Cleared Sep 14, 2007
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445
Nucletron Corp.
Radiology · 15d
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 Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052
Varian Medical Systems, Inc.
Radiology · 28d
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
Cleared Nov 13, 1995
ADVANTAGE SIM
K951830
General Electric Co.
Radiology · 207d
Cleared Oct 25, 1995
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
K945838
Toshiba America Medical Systems, In.C
Radiology · 330d
Cleared Mar 31, 1995
SIMVIEW(TM) 3000
K946053
Siemens Medical Solutions USA, Inc.
Radiology · 109d
Cleared Nov 02, 1992
CMS RECORD AND VERIFY
K921108
Computerized Medical Systems, Inc.
Radiology · 238d
Cleared Oct 27, 1992
ACQSIM SIMULATOR/LOCALIZER
K923851
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Oct 17, 1991
MODULEX RTP SYSTEM
K913017
Computerized Medical Systems, Inc.
Radiology · 100d
Cleared Sep 19, 1991
XIMATRON/CT OPTION
K910647
Fischer Imaging Corp.
Radiology · 218d

About Product Code KPQ - Regulatory Context