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 Siemens Medical Solutions USA, Inc., RaySearch Laboratories AB (PUBL) and Varian Medical Systems, Inc..
255
Total
255
Cleared
117d
Avg days
1995
Since
255 devices
Cleared
Dec 04, 2018
Monaco RTP System
Elekta, Inc.
Radiology
33d
Cleared
Jul 10, 2018
3D Bolus Software
3D Bolus, Inc.
Radiology
159d
Cleared
May 18, 2018
Eclipse Treatment Planning System
Varian Medical Systems, Inc.
Radiology
17d
Cleared
May 15, 2018
Astroid Planning App
.Decimal, LLC
Radiology
140d
Cleared
Apr 25, 2018
RayStation 7
RaySearch Laboratories AB (PUBL)
Radiology
72d
Cleared
Mar 27, 2018
Prelude
Medcom GmbH
Radiology
53d
Cleared
Jan 12, 2018
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Aug 24, 2017
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG
Radiology
164d
Cleared
Aug 15, 2017
Eclipse Treatment Planning System
Varian Medical Systems, Inc.
Radiology
28d
Cleared
Jul 05, 2017
Eclipse Treatment Planning System
Varian Medical Systems, Inc.
Radiology
96d
Cleared
Feb 09, 2017
Pinnacle Radiation Therapy Planning System
Philips Medical Systems (Cleveland), Inc.
Radiology
30d
Cleared
Oct 25, 2016
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
62d
Cleared
Sep 16, 2015
syngo VSim
Siemens Medical Solutions USA, Inc.
Radiology
68d
Cleared
Aug 13, 2015
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
83d
Cleared
Mar 20, 2012
SYNGO RT INTERFACE
Siemens Medical Solutions USA, Inc.
Radiology
43d
Cleared
Jun 16, 2010
SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
Siemens Medical Solutions USA, Inc.
Radiology
56d
Cleared
Jun 07, 2006
COHERENCE DOSIMETRIST, MODEL 2.2
Siemens Medical Solutions USA, Inc.
Radiology
49d
Cleared
Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
Siemens Medical Solutions USA, Inc.
Radiology
134d