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
73–96 of 257
Cleared Mar 29, 2019
Monaco RTP System
K190178
Elekta, Inc.
Radiology · 56d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Dec 04, 2018
Monaco RTP System
K183037
Elekta, Inc.
Radiology · 33d
Cleared Jul 10, 2018
3D Bolus Software
K180289
3D Bolus, Inc.
Radiology · 159d
Cleared May 18, 2018
Eclipse Treatment Planning System
K181145
Varian Medical Systems, Inc.
Radiology · 17d
Cleared May 15, 2018
Astroid Planning App
K173940
.Decimal, LLC
Radiology · 140d
Cleared Apr 25, 2018
RayStation 7
K180379
RaySearch Laboratories AB (PUBL)
Radiology · 72d
Cleared Mar 27, 2018
Prelude
K180308
Medcom GmbH
Radiology · 53d
Cleared Jan 12, 2018
syngo.via RT Image Suite
K173635
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
K170750
Brainlab AG
Radiology · 164d
Cleared Aug 15, 2017
Eclipse Treatment Planning System
K172163
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Jul 25, 2017
Radiance V4
K171885
Gmv Soluciones Globales Internet S.A.U.
Radiology · 29d
Cleared Jul 05, 2017
Eclipse Treatment Planning System
K170969
Varian Medical Systems, Inc.
Radiology · 96d
Cleared Jun 27, 2017
RayStation
K171536
RaySearch Laboratories AB (PUBL)
Radiology · 33d
Cleared Mar 02, 2017
RayStation 6
K170355
RaySearch Laboratories AB (PUBL)
Radiology · 24d
Cleared Feb 09, 2017
Pinnacle Radiation Therapy Planning System
K170086
Philips Medical Systems (Cleveland), Inc.
Radiology · 30d
Cleared Oct 25, 2016
syngo.via RT Image Suite
K162370
Siemens Medical Solutions USA, Inc.
Radiology · 62d
Cleared Jun 24, 2016
Precision Treatment Planning System
K161136
Accuray Incorporated
Radiology · 63d
Cleared Apr 08, 2016
RayStation
K160093
RaySearch Laboratories AB (PUBL)
Radiology · 80d
Cleared Feb 25, 2016
MRCAT
K151435
Philips Medical Systems MR Finland
Radiology · 273d
Cleared Feb 16, 2016
Radiance V3
K153368
Gmv Soluciones Globales Internet S.A.U.
Radiology · 85d
Cleared Dec 11, 2015
Panther StereoSeed
K143514
Prowess, Inc.
Radiology · 365d
Cleared Nov 25, 2015
CORVUS Radiation Therapy Planning System
K151469
Best Nomos
Radiology · 177d
Cleared Sep 28, 2015
Onrad Treatment System
K152488
Accuray Incorporated
Radiology · 28d