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
May 06, 2021
Corvus Radiation Therapy Planning System
Best Nomos
Radiology
29d
Cleared
Apr 19, 2021
AI Segmentation
Varian Medical Systems, Inc.
Radiology
145d
Cleared
Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
Brainlab AG
Radiology
113d
Cleared
Mar 12, 2021
Oncospace
Oncospace, Inc.
Radiology
212d
Cleared
Feb 23, 2021
Monaco Rtp System
Elekta Solutions AB
Radiology
154d
Cleared
Feb 12, 2021
4D Integrated Treatment Console
Varian Medical Systems, Inc.
Radiology
51d
Cleared
Sep 24, 2020
RayStation
RaySearch Laboratories AB (PUBL)
Radiology
204d
Cleared
Sep 20, 2020
CORVUS
Best Nomos
Radiology
122d
Cleared
Aug 13, 2020
Syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
73d
Cleared
Jul 10, 2020
Eclipse Treatment Planning System v16.1
Varian Medical Systems, Inc.
Radiology
25d
Cleared
Jun 10, 2020
RayCare 3.1
RaySearch Laboratories AB (PUBL)
Radiology
104d
Cleared
Apr 27, 2020
Panther Stereotactic
Prowess, Inc.
Radiology
133d
Cleared
Apr 09, 2020
ClearCalc
Radformation, Inc.
Radiology
104d
Cleared
Apr 03, 2020
Eclipse Treatment Planning System v16.0
Varian Medical Systems, Inc.
Radiology
25d
Cleared
Jan 24, 2020
MRCAT brain
Philips Medical Systems MR Finland
Radiology
77d
Cleared
Dec 31, 2019
RadCalc Software
Lifeline Software, Inc.
Radiology
26d
Cleared
Dec 13, 2019
decimal3D
.Decimal, LLC
Radiology
87d
Cleared
Sep 18, 2019
Syngo.Via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
48d
Cleared
Jul 08, 2019
RayCare 2.3
RaySearch Laboratories AB (PUBL)
Radiology
46d
Cleared
Jun 19, 2019
RayStation
RaySearch Laboratories AB (PUBL)
Radiology
120d
Cleared
Apr 30, 2019
MRCAT Pelvis
Philips Medical Systems MR Finland
Radiology
197d
Cleared
Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG
Radiology
28d
Cleared
Mar 29, 2019
Monaco RTP System
Elekta, Inc.
Radiology
56d
Cleared
Feb 21, 2019
Sensus TPS Workstation
Sensus Healthcare, Inc.
Radiology
149d