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., RaySearch Laboratories AB (PUBL) and Siemens Medical Solutions USA, Inc..

257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
169–192 of 257
Cleared Jun 23, 2004
ACCUSOFT
K040474
Direx Systems Corp.
Radiology · 120d
Cleared Oct 09, 2003
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724
Adac Laboratories
Radiology · 36d
Cleared Aug 21, 2003
NOMOS CORVUS 5.0M
K032209
Nomos Corp.
Radiology · 34d
Cleared Aug 07, 2003
OTP 1.2
K031349
Nucletron Corp.
Radiology · 100d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Oct 24, 2002
SPOT PRO (220V), MODEL 131.099
K022741
Nucletron Corporation
Radiology · 66d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027
Computerized Medical Systems, Inc.
Radiology · 277d
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 Dec 05, 2001
FOCAL SIM
K013112
Computerized Medical Systems, Inc.
Radiology · 78d
Cleared Jul 12, 2001
VARISEED 7.0
K012017
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
K010784
Nucletron Corp.
Radiology · 26d
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 Oct 13, 2000
FOCUS
K002147
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675
Nomos Corp.
Radiology · 309d
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
Cleared Jun 02, 2000
OPTIRAD
K993895
Permedics, Inc.
Radiology · 199d
Cleared May 24, 2000
PROTON VISION
K000922
Varian Assoc., Inc.
Radiology · 63d
Cleared Apr 07, 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923
Adac Laboratories
Radiology · 141d
Cleared Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303
Nucletron Corp.
Radiology · 263d
Cleared Mar 09, 2000
BRACHYVISION 6.0
K992762
Varian Assoc., Inc.
Radiology · 205d