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
121–144 of 257
Cleared Dec 28, 2012
ONQ RTS
K123357
Oncology Systems, Inc.
Radiology · 58d
Cleared Dec 07, 2012
VITESSE 3.0
K123152
Varian Medical Systems, Oncology Systems
Radiology · 59d
Cleared Jul 02, 2012
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
K121448
Elekta Inc. D/B/A Nucletron Corporation
Radiology · 48d
Cleared Jun 08, 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551
Simuplan S.L.
Radiology · 106d
Cleared Apr 06, 2012
RAYSTATION
K120387
Raysearch Laboratories AB
Radiology · 59d
Cleared Mar 20, 2012
SYNGO RT INTERFACE
K120363
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Feb 08, 2012
EPIGRAY
K112723
Dosisoft SA
Radiology · 142d
Cleared Jan 06, 2012
RADIANCE
K112060
Gmv Aerospace and Defence S.A.
Radiology · 171d
Cleared Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776
Tomotherapy Incorporated
Radiology · 87d
Cleared Dec 12, 2011
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
K113102
Nucletron
Radiology · 54d
Cleared Oct 17, 2011
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
K111311
Omisa Inc. (Segasist Technologies)
Radiology · 160d
Cleared Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446
Tomotherapy Incorporated
Radiology · 44d
Cleared Sep 15, 2011
EQUAL DOSE
K103515
Nucletron Corporation
Radiology · 289d
Cleared Jun 24, 2011
MONACO RTP SYSTEM
K110730
Computerized Medical Systems, Inc.
Radiology · 100d
Cleared Mar 16, 2011
IPLAN RT
K103246
Brainlab AG
Radiology · 133d
Cleared Dec 21, 2010
LEKSELL GAMMAPLAN
K103093
Elekta Instrument AB
Radiology · 63d
Cleared Oct 01, 2010
XIO RTP SYSTEM
K102216
Computerized Medical Systems, Inc.
Radiology · 56d
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 Sep 24, 2009
XIO RTP SYSTEM
K092132
Computerized Medical Systems, Inc.
Radiology · 71d
Cleared Jul 20, 2009
LEKSELL GAMMAPLAN
K090972
Elekta Instrument AB
Radiology · 105d
Cleared Jul 16, 2009
MONACO RTP SYSTEM, VMAT OPTION
K091179
Computerized Medical Systems, Inc.
Radiology · 84d
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