System, Planning, Radiation Therapy Treatment
FDA product code MUJ · 235 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.5050
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1995-02-16 – 2026-07-08
MUJ
2012-07-02
MUJ
2012-06-08
SIMUPLAN TREATMENT PLANNING SYSTEM
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MUJ
2012-04-06
RAYSTATION
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MUJ
2012-03-20
SYNGO RT INTERFACE
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MUJ
2012-02-08
EPIGRAY
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MUJ
2012-01-06
RADIANCE
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MUJ
2011-12-22
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
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MUJ
2011-12-12
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
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MUJ
2011-10-17
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
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MUJ
2011-10-07
TOMOTHERAPY TREATMENT SYSTEM
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MUJ
2011-09-15
EQUAL DOSE
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MUJ
2011-06-24
MONACO RTP SYSTEM
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MUJ
2011-03-16
IPLAN RT
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MUJ
2011-03-11
ISOGRAY TREATMENT PLANNING SYSTEM
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MUJ
2011-01-12
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
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MUJ
2010-12-21
LEKSELL GAMMAPLAN
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MUJ
2010-11-05
EXPLORER 4D TREATMENT PLANNING SYSTEM
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MUJ
2010-10-01
XIO RTP SYSTEM
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MUJ
2010-09-03
ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2010-07-27
PROWESS PANTHER PROARC, MODEL VERSION 5.0
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MUJ
2010-06-16
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
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MUJ
2010-05-07
MEDCOM RT-VIEWER SYSTEM
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MUJ
2010-04-08
XKNIFE 5
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MUJ
2010-03-12
RAYSTATION VERSION 1.0
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MUJ
2010-02-23
CORVUS RADIATION THERAPY PLANNING SYSTEM
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MUJ
2010-01-11
EXPLORER 4D TREATMENT PLANNING SYSTEM
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MUJ
2009-12-23
SIMUPLAN TREATMENT PLANNING SYSTEM
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MUJ
2009-12-16
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
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MUJ
2009-09-24
XIO RTP SYSTEM
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MUJ
2009-07-20
LEKSELL GAMMAPLAN
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MUJ
2009-07-16
MONACO RTP SYSTEM, VMAT OPTION
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MUJ
2009-07-15
TIGRT TPS
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MUJ
2009-06-18
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2009-05-27
FLEXIPLAN 3D AND 3D+
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MUJ
2009-05-27
RADCALC SOFTWARE, VERSION 6.0
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MUJ
2009-05-05
PANTHER REALART, MODEL 4.7
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MUJ
2009-05-04
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
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MUJ
2009-05-01
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
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MUJ
2009-04-13
P.D SOFTWARE
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MUJ
2009-04-03
PINNACLE3 SMARTARC
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MUJ
2009-03-02
RADIONICS XKNIFE HDRT SYSTEM
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MUJ
2009-01-22
RAYAUTOPLAN 1.0
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MUJ
2008-11-10
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
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MUJ
2008-11-07
ONCENTRA RT VIEWER 1.0
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MUJ
2008-10-22
RAYDOSE
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MUJ
2008-08-25
MODIFICATION TO HI-ART TREATMENT SYSTEM
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MUJ
2008-07-29
FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
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MUJ
2008-06-11
MODEIFICATION TO IPLAN RT DOSE
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MUJ
2008-06-06
ERGO++ VERSION 1.7
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MUJ
2008-05-20
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
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MUJ
2008-04-16
ONCENTRA GYN
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MUJ
2007-12-19
ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2007-11-09
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2007-10-01
MONACO RTP SYSTEM
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MUJ
2007-08-09
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2006-12-21
INTEGRA RADIONICS IMAGEFUSION 3
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MUJ
2006-12-14
CROSSPLAN / ACCUSOFT-XL V.4.04
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MUJ
2006-10-30
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
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MUJ
2006-10-05
ACCUSOFT, ACCUSOFT XL
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MUJ
2006-09-28
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
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MUJ
2006-07-25
INTEGRA RADIONICS XKNIFE RT 4
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MUJ
2006-07-12
IPLAN RT DOSE
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MUJ
2006-06-27
P.D
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MUJ
2006-06-07
COHERENCE DOSIMETRIST, MODEL 2.2
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MUJ
2005-11-03
ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2005-09-14
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
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MUJ
2005-08-09
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
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MUJ
2005-07-18
VITESSE 2.0
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MUJ
2005-05-20
WIMRT MODULE FOR ARTP PLANNING SYSTEM
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MUJ
2005-01-12
ODYSSEY
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MUJ
2004-11-03
HI-ART SYSTEM
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MUJ
2004-09-08
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
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MUJ
2004-08-27
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
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MUJ
2004-07-26
ECLIPSE WITH AAA
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MUJ
2004-07-23
TRIMED PLAN, VERSION 2.2
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MUJ
2004-07-22
ONCENTRA-VISIR
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MUJ
2004-06-23
ACCUSOFT
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MUJ
2004-05-11
STANDARD IMAGING E.IMRT CALCULATOR
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MUJ
2003-12-23
ERGO SRS
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MUJ
2003-10-16
PROWESS
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MUJ
2003-10-09
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
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MUJ
2003-09-17
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
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MUJ
2003-09-03
CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
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MUJ
2003-08-21
NOMOS CORVUS 5.0M
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MUJ
2003-08-07
OTP 1.2
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MUJ
2003-01-31
RTDOSEPLAN
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MUJ
2002-11-05
SIEMENS VIRTUAL SIMULATION (VSIM)
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MUJ
2002-10-24
SPOT PRO (220V), MODEL 131.099
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MUJ
2002-10-08
KONRAD, MODEL V.2.0
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MUJ
2002-10-08
FOCUS RADIATION TREATMENT PLANNING SYSTEM
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MUJ
2002-09-20
PRECISEPLAN 2.0
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MUJ
2002-09-12
ACQPLAN 5.0
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MUJ
2002-06-06
DCM 2.0
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MUJ
2002-05-22
ECLIPSE, HELIOS OPTION
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MUJ
2002-03-12
PREFERNCE IMRT TREATMENT PLANNING MODULE
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MUJ
2002-01-28
HI-ART SYSTEM
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MUJ
2002-01-18
EVTOOL MODEL # V. 1.0
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MUJ
2001-12-05
FOCAL SIM
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MUJ
2001-12-03
XPLAN 2.2 WITH THE BODY SYSTEM
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MUJ
2001-10-18
ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS
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