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
145–168 of 257
Cleared Nov 07, 2008
ONCENTRA RT VIEWER 1.0
K082642
Nucletron Corporation
Radiology · 57d
Cleared Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
K080888
Brainlab AG
Radiology · 72d
Cleared May 20, 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K081281
Nucletron Corporation
Radiology · 14d
Cleared Apr 16, 2008
ONCENTRA GYN
K080929
Nucletron Corporation
Radiology · 15d
Cleared Dec 19, 2007
ECLIPSE TREATMENT PLANNING SYSTEM
K073020
Varian Medical Systems, Inc.
Radiology · 54d
Cleared Nov 09, 2007
MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM
K071760
Varian Medical Systems, Inc.
Radiology · 133d
Cleared Oct 01, 2007
MONACO RTP SYSTEM
K071938
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873
Varian Medical Systems, Inc.
Radiology · 34d
Cleared Dec 14, 2006
CROSSPLAN / ACCUSOFT-XL V.4.04
K063482
Direx Systems Corp.
Radiology · 27d
Cleared Oct 05, 2006
ACCUSOFT, ACCUSOFT XL
K062032
Direx Systems Corp.
Radiology · 79d
Cleared Sep 28, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514
Accuray Incorporated
Radiology · 31d
Cleared Jul 12, 2006
IPLAN RT DOSE
K053584
Brainlab AG
Radiology · 201d
Cleared Jun 07, 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 03, 2005
ECLIPSE TREATMENT PLANNING SYSTEM
K050296
Varian Medical Systems
Radiology · 269d
Cleared Sep 14, 2005
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325
Accuray Incorporated
Radiology · 20d
Cleared Jul 18, 2005
VITESSE 2.0
K051497
Varian Medical Systems, Inc.
Radiology · 42d
Cleared May 20, 2005
WIMRT MODULE FOR ARTP PLANNING SYSTEM
K041971
Prodigm Group, Inc.
Radiology · 302d
Cleared Jan 12, 2005
ODYSSEY
K042861
Permedics, Inc.
Radiology · 89d
Cleared Nov 03, 2004
HI-ART SYSTEM
K042739
Tomotherapy Incorporated
Radiology · 30d
Cleared Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269
Elekta Instrument AB
Radiology · 16d
Cleared Aug 27, 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997
Radionics, A Division of Tyco Healthcare Group LP
Radiology · 32d
Cleared Jul 26, 2004
ECLIPSE WITH AAA
K041403
Varian Medical Systems
Radiology · 61d
Cleared Jul 22, 2004
ONCENTRA-VISIR
K041719
Nucletron Corp.
Radiology · 28d
Cleared Jun 23, 2004
ACCUSOFT
K040474
Direx Systems Corp.
Radiology · 120d