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
Apr 22, 2024
ART-Plan (v.2.2.0)
Therapanacea Sas
Radiology
122d
Cleared
Dec 22, 2023
ART-Plan
Therapanacea
Radiology
128d
Cleared
Dec 15, 2023
Panther TPS
Prowess, Inc.
Radiology
177d
Cleared
Sep 08, 2023
VariSeed (v10)
Varian Medical Systems
Radiology
29d
Cleared
Jul 10, 2023
MOZI TPS
Manteia Technologies Co., Ltd.
Radiology
209d
Cleared
May 26, 2023
Eclipse Treatment Planning System (v18.0)
Varian Medical Systems, Inc.
Radiology
87d
Cleared
May 17, 2023
Radiation Planning Assistant (RPA)
University of Texas, MD Anderson Cancer Center
Radiology
251d
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
Feb 02, 2023
Oncospace
Oncospace, Inc.
Radiology
139d
Cleared
Sep 07, 2022
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Radiology
174d
Cleared
Aug 25, 2022
MRI Planner
Spectronic Medical AB
Radiology
437d
Cleared
Aug 22, 2022
ClearCalc Model RADCA V2
Radformation, Inc.
Radiology
174d
Cleared
May 17, 2022
Monaco RTP System
Elekta Solutions AB
Radiology
162d
Cleared
Apr 15, 2022
RayStation 11B
RaySearch Laboratories AB (PUBL)
Radiology
87d
Cleared
Apr 08, 2022
INT Contour
Carina Medical, LLC
Radiology
262d
Cleared
Apr 05, 2022
MRCAT Head & Neck
Philips OY
Radiology
99d
Cleared
Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Adaptiiv
Radiology
89d
Cleared
Sep 08, 2021
RayStation 11.0
RaySearch Laboratories AB (PUBL)
Radiology
84d
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
Jul 01, 2021
decimal Bolus
.Decimal, LLC
Radiology
48d
Cleared
Jun 29, 2021
RayStation 10.1
RaySearch Laboratories AB (PUBL)
Radiology
118d