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
193–216 of 257
Cleared Jan 13, 2000
ITP, MODEL 1.0
K992434
Nucletron Corp.
Radiology · 176d
Cleared Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766
Helax AB
Radiology · 30d
Cleared Nov 18, 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K990475
Kps & Assoc., Inc.
Radiology · 275d
Cleared Sep 09, 1999
RENDER-PLAN 3-D
K992864
Precision Therapy Intl., Inc.
Radiology · 15d
Cleared Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753
Varian Assoc., Inc.
Radiology · 18d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237
Radionics, Inc.
Radiology · 140d
Cleared Aug 13, 1999
EXPLORER 3D
K991815
Our Scientific Intl., Inc.
Radiology · 78d
Cleared Aug 09, 1999
CADPLAN HELIOS OPTION 6.0
K984532
Varian Medical Systems, Inc.
Radiology · 231d
Cleared Apr 02, 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343
Nucletron Corp.
Radiology · 191d
Cleared Apr 01, 1999
INTERPLANT
K982696
Burdette Medical Systems, Inc.
Radiology · 241d
Cleared Feb 08, 1999
IMAGEFUSION 2.0
K990071
Radionics, Inc.
Radiology · 28d
Cleared Dec 30, 1998
ROCS TPS
K982791
Radiation Oncology Computer Systems
Radiology · 142d
Cleared Dec 11, 1998
STRATA, MODEL V.O.95
K981678
Rosses Medical Systems
Radiology · 213d
Cleared Dec 11, 1998
MODIFICATION TO PROWESS PRO-SIM
K984196
Ssgi Prowess Systems
Radiology · 18d
Cleared Nov 05, 1998
MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
K982821
Multimedia Medical Systems, Inc.
Radiology · 86d
Cleared Sep 02, 1998
ACQPLAN
K974770
Philips Medical Systems (Cleveland), Inc.
Radiology · 254d
Cleared Feb 16, 1995
FOCUS RTP
K915691
Computerized Medical Systems, Inc.
Radiology · 1151d