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
Jun 23, 2004
ACCUSOFT
Direx Systems Corp.
Radiology
120d
Cleared
Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Adac Laboratories
Radiology
36d
Cleared
Aug 21, 2003
NOMOS CORVUS 5.0M
Nomos Corp.
Radiology
34d
Cleared
Aug 07, 2003
OTP 1.2
Nucletron Corp.
Radiology
100d
Cleared
Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
Siemens Medical Solutions USA, Inc.
Radiology
134d
Cleared
Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
Nucletron Corporation
Radiology
66d
Cleared
Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
Computerized Medical Systems, Inc.
Radiology
277d
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
Dec 05, 2001
FOCAL SIM
Computerized Medical Systems, Inc.
Radiology
78d
Cleared
Jul 12, 2001
VARISEED 7.0
Varian Medical Systems
Radiology
14d
Cleared
Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
Nucletron Corp.
Radiology
26d
Cleared
Feb 02, 2001
P3IMRT TM
Adac Laboratories
Radiology
193d
Cleared
Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
Brainlab AG
Radiology
80d
Cleared
Oct 13, 2000
FOCUS
Computerized Medical Systems, Inc.
Radiology
88d
Cleared
Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
Nomos Corp.
Radiology
309d
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
Cleared
Jun 02, 2000
OPTIRAD
Permedics, Inc.
Radiology
199d
Cleared
May 24, 2000
PROTON VISION
Varian Assoc., Inc.
Radiology
63d
Cleared
Apr 07, 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
Adac Laboratories
Radiology
141d
Cleared
Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
Nucletron Corp.
Radiology
263d
Cleared
Mar 09, 2000
BRACHYVISION 6.0
Varian Assoc., Inc.
Radiology
205d