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