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 Brainlab AG.
252
Total
252
Cleared
116d
Avg days
1995
Since
252 devices
Cleared
Mar 29, 2023
RayStation 12A
RaySearch Laboratories AB (PUBL)
Radiology
240d
Cleared
Mar 14, 2023
RT Elements (4.0)
Brainlab AG
Radiology
141d
Cleared
Feb 23, 2023
Monaco RTP System
Elekta Solutions AB
Radiology
127d
Cleared
Sep 07, 2022
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
174d
Cleared
Sep 02, 2021
AI Segmentation
Varian Medical Systems, Inc.
Radiology
73d
Cleared
Jul 30, 2021
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
87d
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
Feb 12, 2021
4D Integrated Treatment Console
Varian Medical Systems, Inc.
Radiology
51d