System, Planning, Radiation Therapy Treatment
FDA product code MUJ · 235 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.5050
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1995-02-16 – 2026-07-08
MUJ
2026-07-08
MUJ
2026-06-18
RadOncAI
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MUJ
2026-05-27
Multimodality Simulation Workspace (MM Sim) (v1.0.0)
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MUJ
2026-05-22
eXaSkin Plus
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MUJ
2026-05-14
ART.1-US
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MUJ
2026-03-18
syngo.via RT Image Suite VC10
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MUJ
2026-02-19
TrueFit Bolus
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MUJ
2026-02-19
Monaco RTP System (6.3)
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MUJ
2025-12-23
ART-Plan+ (v3.1.0)
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MUJ
2025-12-22
RayStation (2024A SP3)
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MUJ
2025-12-19
ClearCalc Model RADCA V2.6
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MUJ
2025-11-20
PlanOne 1
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MUJ
2025-09-04
Dose+ (1.0)
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MUJ
2025-06-17
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
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MUJ
2025-04-17
RayCare (2024A SP1)
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MUJ
2025-04-11
Oncospace
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MUJ
2025-04-04
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
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MUJ
2025-02-25
ART-Plan+ (v.3.0.0)
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MUJ
2024-12-13
ARIA Radiation Therapy Management System (18.1)
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MUJ
2024-12-11
Eclipse Treatment Planning System (18.1)
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MUJ
2024-12-04
XBeam (v2)
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MUJ
2024-10-23
TrueFit Bolus; TrueFlex Bolus
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MUJ
2024-10-23
Vitesse (5.0)
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MUJ
2024-08-30
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
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MUJ
2024-05-17
Radiance V5
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MUJ
2024-04-26
syngo.via RT Image Suite
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MUJ
2024-04-22
ART-Plan (v.2.2.0)
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MUJ
2023-12-22
ART-Plan
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MUJ
2023-12-15
Panther TPS
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MUJ
2023-09-08
VariSeed (v10)
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MUJ
2023-07-10
MOZI TPS
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MUJ
2023-05-26
Eclipse Treatment Planning System (v18.0)
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MUJ
2023-05-17
Radiation Planning Assistant (RPA)
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MUJ
2023-03-29
RayStation 12A
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MUJ
2023-03-14
RT Elements (4.0)
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MUJ
2023-02-23
Monaco RTP System
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MUJ
2023-02-02
Oncospace
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MUJ
2022-09-07
syngo.via RT Image Suite
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MUJ
2022-08-25
MRI Planner
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MUJ
2022-08-22
ClearCalc Model RADCA V2
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MUJ
2022-05-17
Monaco RTP System
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MUJ
2022-04-15
RayStation 11B
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MUJ
2022-04-08
INT Contour
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MUJ
2022-04-05
MRCAT Head & Neck
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MUJ
2022-01-19
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
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MUJ
2021-09-08
RayStation 11.0
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MUJ
2021-09-02
AI Segmentation
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MUJ
2021-07-30
syngo.via RT Image Suite
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MUJ
2021-07-01
decimal Bolus
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MUJ
2021-06-29
RayStation 10.1
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MUJ
2021-05-06
Corvus Radiation Therapy Planning System
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MUJ
2021-04-19
AI Segmentation
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MUJ
2021-04-09
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
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MUJ
2021-03-12
Oncospace
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MUJ
2021-02-23
Monaco Rtp System
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MUJ
2021-02-12
4D Integrated Treatment Console
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MUJ
2020-09-24
RayStation
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MUJ
2020-09-20
CORVUS
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MUJ
2020-08-13
Syngo.via RT Image Suite
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MUJ
2020-07-10
Eclipse Treatment Planning System v16.1
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MUJ
2020-06-10
RayCare 3.1
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MUJ
2020-04-27
Panther Stereotactic
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MUJ
2020-04-09
ClearCalc
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MUJ
2020-04-03
Eclipse Treatment Planning System v16.0
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MUJ
2020-01-24
MRCAT brain
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MUJ
2019-12-31
RadCalc Software
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MUJ
2019-12-13
decimal3D
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MUJ
2019-09-18
Syngo.Via RT Image Suite
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MUJ
2019-07-08
RayCare 2.3
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MUJ
2019-06-19
RayStation
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MUJ
2019-04-30
MRCAT Pelvis
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MUJ
2019-04-12
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
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MUJ
2019-03-29
Monaco RTP System
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MUJ
2019-02-21
Sensus TPS Workstation
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MUJ
2018-12-04
Monaco RTP System
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MUJ
2018-07-10
3D Bolus Software
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MUJ
2018-05-18
Eclipse Treatment Planning System
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MUJ
2018-05-15
Astroid Planning App
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MUJ
2018-04-25
RayStation 7
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MUJ
2018-03-27
Prelude
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MUJ
2018-01-12
syngo.via RT Image Suite
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MUJ
2017-08-24
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
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MUJ
2017-08-15
Eclipse Treatment Planning System
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MUJ
2017-07-25
Radiance V4
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MUJ
2017-07-05
Eclipse Treatment Planning System
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MUJ
2017-06-27
RayStation
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MUJ
2017-03-02
RayStation 6
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MUJ
2017-02-09
Pinnacle Radiation Therapy Planning System
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MUJ
2016-10-25
syngo.via RT Image Suite
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MUJ
2016-06-24
Precision Treatment Planning System
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MUJ
2016-04-08
RayStation
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MUJ
2016-02-25
MRCAT
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MUJ
2016-02-16
Radiance V3
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MUJ
2013-11-20
MONACO
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MUJ
2013-09-25
ECLIPSE TREATMENT PLANNING SYSTEM
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MUJ
2013-07-16
RADVISION
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MUJ
2013-05-10
RAYSTATION
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MUJ
2013-04-04
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
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MUJ
2012-12-28
ONQ RTS
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MUJ
2012-12-07
VITESSE 3.0
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