FDA Product Code MUJ: System, Planning, Radiation Therapy Treatment
Precision in radiation therapy begins before the first beam is delivered. FDA product code MUJ covers radiation therapy treatment planning systems.
These software platforms import patient imaging data, define target volumes and critical structures, and calculate optimized dose distributions for external beam and brachytherapy treatments. They are the computational backbone of modern radiotherapy and work in conjunction with linear accelerators and brachytherapy systems.
MUJ devices are Class II medical devices, regulated under 21 CFR 892.5050 and reviewed by the FDA Radiology panel.
Leading manufacturers include Varian Medical Systems, Inc., Siemens Medical Solutions USA, Inc. and RaySearch Laboratories AB (PUBL).
257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
Cleared
Mar 16, 2011
IPLAN RT
Brainlab AG
Radiology
133d
Cleared
Dec 21, 2010
LEKSELL GAMMAPLAN
Elekta Instrument AB
Radiology
63d
Cleared
Sep 03, 2010
ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
49d
Cleared
Jun 16, 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
Siemens Medical Solutions USA, Inc.
Radiology
56d
Cleared
Jul 20, 2009
LEKSELL GAMMAPLAN
Elekta Instrument AB
Radiology
105d
Cleared
Jun 18, 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
29d
Cleared
Apr 03, 2009
PINNACLE3 SMARTARC
Philips Medical Systems, Inc.
Radiology
9d
Cleared
Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
Brainlab AG
Radiology
72d
Cleared
Dec 19, 2007
ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
54d
Cleared
Nov 09, 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
133d
Cleared
Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
Varian Medical Systems, Inc.
Radiology
34d
Cleared
Jul 12, 2006
IPLAN RT DOSE
Brainlab AG
Radiology
201d
Cleared
Jun 07, 2006
COHERENCE DOSIMETRIST, MODEL 2.2
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Jul 18, 2005
VITESSE 2.0
Varian Medical Systems, Inc.
Radiology
42d
Cleared
Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
Elekta Instrument AB
Radiology
16d
Cleared
Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Adac Laboratories
Radiology
36d
Cleared
Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Sep 12, 2002
ACQPLAN 5.0
Philips Medical Systems, Inc.
Radiology
311d
Cleared
May 22, 2002
ECLIPSE, HELIOS OPTION
Varian Medical Systems, Inc.
Radiology
30d
Cleared
Feb 02, 2001
P3IMRT TM
Adac Laboratories
Radiology
193d
Cleared
Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
Brainlab AG
Radiology
80d
Cleared
Aug 30, 2000
PROTON VISION 7.0
Varian Medical Systems, Inc.
Radiology
30d
Cleared
Jul 13, 2000
BRAINSCAN
Brainlab AG
Radiology
197d
Cleared
Jun 28, 2000
XPLAN 2.1
Radionics, Inc.
Radiology
23d