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 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
25–48 of 255
Cleared Apr 22, 2024
ART-Plan (v.2.2.0)
K234068
Therapanacea Sas
Radiology · 122d
Cleared Dec 22, 2023
ART-Plan
K232479
Therapanacea
Radiology · 128d
Cleared Dec 15, 2023
Panther TPS
K231825
Prowess, Inc.
Radiology · 177d
Cleared Sep 08, 2023
VariSeed (v10)
K232400
Varian Medical Systems
Radiology · 29d
Cleared Jul 10, 2023
MOZI TPS
K223724
Manteia Technologies Co., Ltd.
Radiology · 209d
Cleared May 26, 2023
Eclipse Treatment Planning System (v18.0)
K230557
Varian Medical Systems, Inc.
Radiology · 87d
Cleared May 17, 2023
Radiation Planning Assistant (RPA)
K222728
University of Texas, MD Anderson Cancer Center
Radiology · 251d
Cleared Mar 29, 2023
RayStation 12A
K222312
RaySearch Laboratories AB (PUBL)
Radiology · 240d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279
Brainlab AG
Radiology · 141d
Cleared Feb 23, 2023
Monaco RTP System
K223233
Elekta Solutions AB
Radiology · 127d
Cleared Feb 02, 2023
Oncospace
K222803
Oncospace, Inc.
Radiology · 139d
Cleared Sep 07, 2022
syngo.via RT Image Suite
K220783
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Aug 25, 2022
MRI Planner
K211841
Spectronic Medical AB
Radiology · 437d
Cleared Aug 22, 2022
ClearCalc Model RADCA V2
K220582
Radformation, Inc.
Radiology · 174d
Cleared May 17, 2022
Monaco RTP System
K213787
Elekta Solutions AB
Radiology · 162d
Cleared Apr 15, 2022
RayStation 11B
K220141
RaySearch Laboratories AB (PUBL)
Radiology · 87d
Cleared Apr 08, 2022
INT Contour
K212274
Carina Medical, LLC
Radiology · 262d
Cleared Apr 05, 2022
MRCAT Head & Neck
K214081
Philips OY
Radiology · 99d
Cleared Jan 19, 2022
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
K213438
Adaptiiv
Radiology · 89d
Cleared Sep 08, 2021
RayStation 11.0
K211867
RaySearch Laboratories AB (PUBL)
Radiology · 84d
Cleared Sep 02, 2021
AI Segmentation
K211881
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Jul 30, 2021
syngo.via RT Image Suite
K211379
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jul 01, 2021
decimal Bolus
K211511
.Decimal, LLC
Radiology · 48d
Cleared Jun 29, 2021
RayStation 10.1
K210645
RaySearch Laboratories AB (PUBL)
Radiology · 118d