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 Varian Medical Systems, Inc., Brainlab AG and Siemens Medical Solutions USA, Inc..

15
Total
15
Cleared
123d
Avg days
2021
Since

List of System, Planning, Radiation Therapy Treatment devices cleared through 510(k)

15 devices
1–15 of 15
Cleared Mar 18, 2026
syngo.via RT Image Suite VC10
K252304
Varian Medical Systems, Inc.
Radiology · 237d
Cleared Jun 17, 2025
RT Elements (4.5)
K250440
Brainlab AG
Radiology · 123d
Cleared Dec 13, 2024
ARIA Radiation Therapy Management System (18.1)
K242463
Varian Medical Systems, Inc.
Radiology · 116d
Cleared Dec 11, 2024
Eclipse Treatment Planning System (18.1)
K242378
Varian Medical Systems
Radiology · 124d
Cleared Oct 23, 2024
Vitesse (5.0)
K241876
Varian Medical Systems
Radiology · 117d
Cleared Apr 26, 2024
syngo.via RT Image Suite
K232799
Siemens Medical Solutions USA, Inc.
Radiology · 227d
Cleared Sep 08, 2023
VariSeed (v10)
K232400
Varian Medical Systems
Radiology · 29d
Cleared May 26, 2023
Eclipse Treatment Planning System (v18.0)
K230557
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Mar 14, 2023
RT Elements (4.0)
K223279
Brainlab AG
Radiology · 141d
Cleared Sep 07, 2022
syngo.via RT Image Suite
K220783
Siemens Medical Solutions USA, Inc.
Radiology · 174d
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 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 Feb 12, 2021
4D Integrated Treatment Console
K203766
Varian Medical Systems, Inc.
Radiology · 51d

How to use this database

This page lists all FDA 510(k) submissions for System, Planning, Radiation Therapy Treatment devices (product code MUJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →