MUJ · Class II · 21 CFR 892.5050

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
97–120 of 257
Cleared Mar 16, 2011
IPLAN RT
K103246
Brainlab AG
Radiology · 133d
Cleared Dec 21, 2010
LEKSELL GAMMAPLAN
K103093
Elekta Instrument AB
Radiology · 63d
Cleared Sep 03, 2010
ECLIPSE TREATMENT PLANNING SYSTEM
K102011
Varian Medical Systems, Inc.
Radiology · 49d
Cleared Jun 16, 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
K101119
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Jul 20, 2009
LEKSELL GAMMAPLAN
K090972
Elekta Instrument AB
Radiology · 105d
Cleared Jun 18, 2009
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K091492
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Apr 03, 2009
PINNACLE3 SMARTARC
K090808
Philips Medical Systems, Inc.
Radiology · 9d
Cleared Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
K080888
Brainlab AG
Radiology · 72d
Cleared Dec 19, 2007
ECLIPSE TREATMENT PLANNING SYSTEM
K073020
Varian Medical Systems, Inc.
Radiology · 54d
Cleared Nov 09, 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760
Varian Medical Systems, Inc.
Radiology · 133d
Cleared Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873
Varian Medical Systems, Inc.
Radiology · 34d
Cleared Jul 12, 2006
IPLAN RT DOSE
K053584
Brainlab AG
Radiology · 201d
Cleared Jun 07, 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jul 18, 2005
VITESSE 2.0
K051497
Varian Medical Systems, Inc.
Radiology · 42d
Cleared Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269
Elekta Instrument AB
Radiology · 16d
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724
Adac Laboratories
Radiology · 36d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Sep 12, 2002
ACQPLAN 5.0
K013644
Philips Medical Systems, Inc.
Radiology · 311d
Cleared May 22, 2002
ECLIPSE, HELIOS OPTION
K021268
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 02, 2001
P3IMRT TM
K002237
Adac Laboratories
Radiology · 193d
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509
Brainlab AG
Radiology · 80d
Cleared Aug 30, 2000
PROTON VISION 7.0
K002312
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Jul 13, 2000
BRAINSCAN
K994413
Brainlab AG
Radiology · 197d
Cleared Jun 28, 2000
XPLAN 2.1
K001700
Radionics, Inc.
Radiology · 23d