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
Jan 13, 2000
ITP, MODEL 1.0
Nucletron Corp.
Radiology
176d
Cleared
Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
Helax AB
Radiology
30d
Cleared
Nov 18, 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
Kps & Assoc., Inc.
Radiology
275d
Cleared
Sep 09, 1999
RENDER-PLAN 3-D
Precision Therapy Intl., Inc.
Radiology
15d
Cleared
Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
Varian Assoc., Inc.
Radiology
18d
Cleared
Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
Radionics, Inc.
Radiology
140d
Cleared
Aug 13, 1999
EXPLORER 3D
Our Scientific Intl., Inc.
Radiology
78d
Cleared
Aug 09, 1999
CADPLAN HELIOS OPTION 6.0
Varian Medical Systems, Inc.
Radiology
231d
Cleared
Apr 02, 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
Nucletron Corp.
Radiology
191d
Cleared
Apr 01, 1999
INTERPLANT
Burdette Medical Systems, Inc.
Radiology
241d
Cleared
Feb 08, 1999
IMAGEFUSION 2.0
Radionics, Inc.
Radiology
28d
Cleared
Dec 30, 1998
ROCS TPS
Radiation Oncology Computer Systems
Radiology
142d
Cleared
Dec 11, 1998
STRATA, MODEL V.O.95
Rosses Medical Systems
Radiology
213d
Cleared
Dec 11, 1998
MODIFICATION TO PROWESS PRO-SIM
Ssgi Prowess Systems
Radiology
18d
Cleared
Nov 05, 1998
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
Multimedia Medical Systems, Inc.
Radiology
86d
Cleared
Sep 02, 1998
ACQPLAN
Philips Medical Systems (Cleveland), Inc.
Radiology
254d
Cleared
Feb 16, 1995
FOCUS RTP
Computerized Medical Systems, Inc.
Radiology
1151d