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., Siemens Medical Solutions USA, Inc. and RaySearch Laboratories AB (PUBL).

257
Total
257
Cleared
117d
Avg days
1995
Since
257 devices
73–96 of 257
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 05, 2017
Eclipse Treatment Planning System
K170969
Varian Medical Systems, Inc.
Radiology · 96d
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 Sep 18, 2015
Eclipse Treatment Planning System
K152393
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Sep 16, 2015
syngo VSim
K151887
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Sep 03, 2015
Leksell GammaPlan
K151666
Elekta Instrument AB
Radiology · 76d
Cleared Aug 13, 2015
syngo.via RT Image Suite
K151380
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108
Brainlab AG
Radiology · 134d
Cleared Sep 05, 2014
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING
K141248
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Aug 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K141283
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Feb 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K133247
Varian Medical Systems, Inc.
Radiology · 108d
Cleared Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
K133331
Varian Medical Systems, Inc.
Radiology · 90d
Cleared Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
K131891
Varian Medical Systems, Inc.
Radiology · 92d
Cleared Mar 20, 2012
SYNGO RT INTERFACE
K120363
Siemens Medical Solutions USA, Inc.
Radiology · 43d