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., Siemens Medical Solutions USA, Inc. and RaySearch Laboratories AB (PUBL).
257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
Cleared
May 24, 2000
PROTON VISION
Varian Assoc., Inc.
Radiology
63d
Cleared
Apr 07, 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
Adac Laboratories
Radiology
141d
Cleared
Mar 09, 2000
BRACHYVISION 6.0
Varian Assoc., Inc.
Radiology
205d
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 09, 1999
CADPLAN HELIOS OPTION 6.0
Varian Medical Systems, Inc.
Radiology
231d
Cleared
Feb 08, 1999
IMAGEFUSION 2.0
Radionics, Inc.
Radiology
28d
Cleared
Sep 02, 1998
ACQPLAN
Philips Medical Systems (Cleveland), Inc.
Radiology
254d