Product code MUJ— Radiology
ECLIPSE TREATMENT PLANNING SYSTEM
- Classification name
- System, Planning, Radiation Therapy Treatment
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Total cleared
- 257
- First cleared
- Most recent
Market context for product code MUJ
FDA has cleared devices under product code MUJ between 1995 and 2026, filed by 95 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code MUJ
Recent clearances under product code MUJ
1–100 of 257- K260750 — Virtual Cone (1.0)
- K253050 — RadOncAI
- K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)
- K252784 — eXaSkin Plus
- K253078 — ART.1-US
- K252304 — syngo.via RT Image Suite VC10
- K252002 — Monaco RTP System (6.3)
- K260308 — TrueFit Bolus
- K253091 — ART-Plan+ (v3.1.0)
- K252109 — RayStation (2024A SP3)
- K252863 — ClearCalc Model RADCA V2.6
- K250963 — PlanOne 1
- K250064 — Dose+ (1.0)
- K250440 — RT Elements (4.5) +11 more
- K242992 — RayCare (2024A SP1)
- K242748 — Oncospace
- K240398 — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
- K242822 — ART-Plan+ (v.3.0.0)
- K242463 — ARIA Radiation Therapy Management System (18.1)
- K242378 — Eclipse Treatment Planning System (18.1)
- K240671 — XBeam (v2)
- K241876 — Vitesse (5.0)
- K243057 — TrueFit Bolus; TrueFlex Bolus
- K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
- K233236 — Radiance V5
- K232799 — syngo.via RT Image Suite
- K234068 — ART-Plan (v.2.2.0)
- K232479 — ART-Plan
- K231825 — Panther TPS
- K232400 — VariSeed (v10)
- K223724 — MOZI TPS
- K230557 — Eclipse Treatment Planning System (v18.0)
- K222728 — Radiation Planning Assistant (RPA)
- K222312 — RayStation 12A
- K223279 — RT Elements (4.0)
- K223233 — Monaco RTP System
- K222803 — Oncospace
- K220783 — syngo.via RT Image Suite
- K211841 — MRI Planner
- K220582 — ClearCalc Model RADCA V2
- K213787 — Monaco RTP System
- K220141 — RayStation 11B
- K212274 — INT Contour
- K214081 — MRCAT Head & Neck
- K213438 — 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
- K211867 — RayStation 11.0
- K211881 — AI Segmentation
- K211379 — syngo.via RT Image Suite
- K211511 — decimal Bolus
- K210645 — RayStation 10.1
- K211034 — Corvus Radiation Therapy Planning System
- K203469 — AI Segmentation
- K203681 — RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
- K202284 — Oncospace
- K202789 — Monaco Rtp System
- K203766 — 4D Integrated Treatment Console
- K200569 — RayStation
- K201350 — CORVUS
- K201444 — Syngo.via RT Image Suite
- K201607 — Eclipse Treatment Planning System v16.1
- K200487 — RayCare 3.1
- K193459 — Panther Stereotactic
- K193640 — ClearCalc
- K200608 — Eclipse Treatment Planning System v16.0
- K193109 — MRCAT brain
- K193381 — RadCalc Software
- K192554 — decimal3D
- K192065 — Syngo.Via RT Image Suite
- K191384 — RayCare 2.3
- K190387 — RayStation
- K182888 — MRCAT Pelvis
- K190664 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K190178 — Monaco RTP System
- K182665 — Sensus TPS Workstation
- K183037 — Monaco RTP System
- K180289 — 3D Bolus Software
- K181145 — Eclipse Treatment Planning System
- K173940 — Astroid Planning App
- K180379 — RayStation 7
- K180308 — Prelude
- K173635 — syngo.via RT Image Suite
- K170750 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
- K172163 — Eclipse Treatment Planning System
- K171885 — Radiance V4
- K170969 — Eclipse Treatment Planning System
- K171536 — RayStation
- K170355 — RayStation 6
- K170086 — Pinnacle Radiation Therapy Planning System
- K162370 — syngo.via RT Image Suite
- K161136 — Precision Treatment Planning System
- K160093 — RayStation
- K151435 — MRCAT
- K153368 — Radiance V3
- K143514 — Panther StereoSeed
- K151469 — CORVUS Radiation Therapy Planning System
- K152488 — Onrad Treatment System
- K152393 — Eclipse Treatment Planning System
- K151887 — syngo VSim
- K151560 — QuickPlan
- K151666 — Leksell GammaPlan
Data sourced from openFDA. This site is unofficial and independent of the FDA.