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
Mar 29, 2019
Monaco RTP System
Elekta, Inc.
Radiology
56d
Cleared
Feb 21, 2019
Sensus TPS Workstation
Sensus Healthcare, Inc.
Radiology
149d
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 25, 2017
Radiance V4
Gmv Soluciones Globales Internet S.A.U.
Radiology
29d
Cleared
Jul 05, 2017
Eclipse Treatment Planning System
Varian Medical Systems, Inc.
Radiology
96d
Cleared
Jun 27, 2017
RayStation
RaySearch Laboratories AB (PUBL)
Radiology
33d
Cleared
Mar 02, 2017
RayStation 6
RaySearch Laboratories AB (PUBL)
Radiology
24d
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
Jun 24, 2016
Precision Treatment Planning System
Accuray Incorporated
Radiology
63d
Cleared
Apr 08, 2016
RayStation
RaySearch Laboratories AB (PUBL)
Radiology
80d
Cleared
Feb 25, 2016
MRCAT
Philips Medical Systems MR Finland
Radiology
273d
Cleared
Feb 16, 2016
Radiance V3
Gmv Soluciones Globales Internet S.A.U.
Radiology
85d
Cleared
Dec 11, 2015
Panther StereoSeed
Prowess, Inc.
Radiology
365d
Cleared
Nov 25, 2015
CORVUS Radiation Therapy Planning System
Best Nomos
Radiology
177d
Cleared
Sep 28, 2015
Onrad Treatment System
Accuray Incorporated
Radiology
28d