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
49–72 of 255
Cleared May 06, 2021
Corvus Radiation Therapy Planning System
K211034
Best Nomos
Radiology · 29d
Cleared Apr 19, 2021
AI Segmentation
K203469
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
K203681
Brainlab AG
Radiology · 113d
Cleared Mar 12, 2021
Oncospace
K202284
Oncospace, Inc.
Radiology · 212d
Cleared Feb 23, 2021
Monaco Rtp System
K202789
Elekta Solutions AB
Radiology · 154d
Cleared Feb 12, 2021
4D Integrated Treatment Console
K203766
Varian Medical Systems, Inc.
Radiology · 51d
Cleared Sep 24, 2020
RayStation
K200569
RaySearch Laboratories AB (PUBL)
Radiology · 204d
Cleared Sep 20, 2020
CORVUS
K201350
Best Nomos
Radiology · 122d
Cleared Aug 13, 2020
Syngo.via RT Image Suite
K201444
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Jul 10, 2020
Eclipse Treatment Planning System v16.1
K201607
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jun 10, 2020
RayCare 3.1
K200487
RaySearch Laboratories AB (PUBL)
Radiology · 104d
Cleared Apr 27, 2020
Panther Stereotactic
K193459
Prowess, Inc.
Radiology · 133d
Cleared Apr 09, 2020
ClearCalc
K193640
Radformation, Inc.
Radiology · 104d
Cleared Apr 03, 2020
Eclipse Treatment Planning System v16.0
K200608
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jan 24, 2020
MRCAT brain
K193109
Philips Medical Systems MR Finland
Radiology · 77d
Cleared Dec 31, 2019
RadCalc Software
K193381
Lifeline Software, Inc.
Radiology · 26d
Cleared Dec 13, 2019
decimal3D
K192554
.Decimal, LLC
Radiology · 87d
Cleared Sep 18, 2019
Syngo.Via RT Image Suite
K192065
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Jul 08, 2019
RayCare 2.3
K191384
RaySearch Laboratories AB (PUBL)
Radiology · 46d
Cleared Jun 19, 2019
RayStation
K190387
RaySearch Laboratories AB (PUBL)
Radiology · 120d
Cleared Apr 30, 2019
MRCAT Pelvis
K182888
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
K190664
Brainlab AG
Radiology · 28d
Cleared Mar 29, 2019
Monaco RTP System
K190178
Elekta, Inc.
Radiology · 56d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665
Sensus Healthcare, Inc.
Radiology · 149d