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., RaySearch Laboratories AB (PUBL) and Siemens Medical Solutions USA, Inc..
257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
Cleared
Dec 28, 2012
ONQ RTS
Oncology Systems, Inc.
Radiology
58d
Cleared
Dec 07, 2012
VITESSE 3.0
Varian Medical Systems, Oncology Systems
Radiology
59d
Cleared
Jul 02, 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
Elekta Inc. D/B/A Nucletron Corporation
Radiology
48d
Cleared
Jun 08, 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
Simuplan S.L.
Radiology
106d
Cleared
Apr 06, 2012
RAYSTATION
Raysearch Laboratories AB
Radiology
59d
Cleared
Mar 20, 2012
SYNGO RT INTERFACE
Siemens Medical Solutions USA, Inc.
Radiology
43d
Cleared
Feb 08, 2012
EPIGRAY
Dosisoft SA
Radiology
142d
Cleared
Jan 06, 2012
RADIANCE
Gmv Aerospace and Defence S.A.
Radiology
171d
Cleared
Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
Tomotherapy Incorporated
Radiology
87d
Cleared
Dec 12, 2011
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
Nucletron
Radiology
54d
Cleared
Oct 17, 2011
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
Omisa Inc. (Segasist Technologies)
Radiology
160d
Cleared
Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
Tomotherapy Incorporated
Radiology
44d
Cleared
Sep 15, 2011
EQUAL DOSE
Nucletron Corporation
Radiology
289d
Cleared
Jun 24, 2011
MONACO RTP SYSTEM
Computerized Medical Systems, Inc.
Radiology
100d
Cleared
Mar 16, 2011
IPLAN RT
Brainlab AG
Radiology
133d
Cleared
Dec 21, 2010
LEKSELL GAMMAPLAN
Elekta Instrument AB
Radiology
63d
Cleared
Oct 01, 2010
XIO RTP SYSTEM
Computerized Medical Systems, Inc.
Radiology
56d
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
Sep 24, 2009
XIO RTP SYSTEM
Computerized Medical Systems, Inc.
Radiology
71d
Cleared
Jul 20, 2009
LEKSELL GAMMAPLAN
Elekta Instrument AB
Radiology
105d
Cleared
Jul 16, 2009
MONACO RTP SYSTEM, VMAT OPTION
Computerized Medical Systems, Inc.
Radiology
84d
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