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Panels › Radiology › Product code MUJ · Class 2

System, Planning, Radiation Therapy Treatment

Regulation 892.5050

13510(k)s in 12 months (258 all time)
13recalls in 12 months (270 all time)
257recalls that name a 510(k)
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Top companies in MUJ

Company510(k)sRecalls
Raysearch Laboratories AB7117
Elekta, Inc.246
Computerized Medical Systems, Inc.931
Varian Medical Systems337
Siemens Medical Solutions USA, Inc.136
Brainlab AG117
Varian Medical Systems, Oncology Systems117
Accuray Incorporated96
RaySearch Laboratories AB (PUBL)150
Nucletron131
Decided510(k)Device and applicantCode
Oct 5, 2026K261655RT Elements (4.6)
Brainlab SE, DE
MUJ
Jul 8, 2026K260750Virtual Cone (1.0)
Varian Medical Systems, Inc.
MUJ
Jun 18, 2026K253050RadOncAI
Informai
MUJ
May 27, 2026K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)
Philips Medical Systems Nederland B.V., NL
MUJ
May 22, 2026K252784eXaSkin Plus
Anatomical Geometry S.L., ES
MUJ
May 14, 2026K253078ART.1-US
Seetreat Pty, Ltd., AU
MUJ
Mar 18, 2026K252304syngo.via RT Image Suite VC10
Varian Medical Systems, Inc.
MUJ
Feb 19, 2026K260308TrueFit Bolus
Adaptiiv Medical Technologies, Inc., CA
MUJ
Feb 19, 2026K252002Monaco RTP System (6.3)
Elekta Solutions AB, SE
MUJ
Dec 23, 2025K253091ART-Plan+ (v3.1.0)
Therapanacea Sas, FR
MUJ
Dec 22, 2025K252109RayStation (2024A SP3)
RaySearch Laboratories AB (PUBL), SE
MUJ
Dec 19, 2025K252863ClearCalc Model RADCA V2.6
Radformation, Inc.
MUJ
Nov 20, 2025K250963PlanOne 1
Cosylab Jsc, Control System Laboratory, SI
MUJ
Sep 4, 2025K250064Dose+ (1.0)
Mvision AI OY, FI
MUJ
Jun 17, 2025K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial
Brainlab AG, DE
MUJ
Apr 17, 2025K242992RayCare (2024A SP1)
RaySearch Laboratories AB (PUBL), SE
MUJ
Apr 11, 2025K242748Oncospace
Oncospace, Inc.
MUJ
Apr 4, 2025K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (PUBL), SE
MUJ
Feb 25, 2025K242822ART-Plan+ (v.3.0.0)
Therapanacea Sas, FR
MUJ
Dec 13, 2024K242463ARIA Radiation Therapy Management System (18.1)
Varian Medical Systems, Inc.
MUJ
Dec 11, 2024K242378Eclipse Treatment Planning System (18.1)
Varian Medical Systems
MUJ
Dec 4, 2024K240671XBeam (v2)
Xstrahl, Ltd., GB
MUJ
Oct 23, 2024K243057TrueFit Bolus; TrueFlex Bolus
Adaptiiv Medical Technologies, Inc., CA
MUJ
Oct 23, 2024K241876Vitesse (5.0)
Varian Medical Systems
MUJ
Aug 30, 2024K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
Adaptiiv Medical Technologies, Inc., CA
MUJ
May 17, 2024K233236Radiance V5
Gmv Soluciones Globales Internet S.A.U., ES
MUJ
Apr 26, 2024K232799syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
MUJ
Apr 22, 2024K234068ART-Plan (v.2.2.0)
Therapanacea Sas, FR
MUJ
Dec 22, 2023K232479ART-Plan
Therapanacea, FR
MUJ
Dec 15, 2023K231825Panther TPS
Prowess, Inc.
MUJ
Sep 8, 2023K232400VariSeed (v10)
Varian Medical Systems
MUJ
Jul 10, 2023K223724MOZI TPS
Manteia Technologies Co., Ltd., CN
MUJ
May 26, 2023K230557Eclipse Treatment Planning System (v18.0)
Varian Medical Systems, Inc.
MUJ
May 17, 2023K222728Radiation Planning Assistant (RPA)
University of Texas, MD Anderson Cancer Center
MUJ
Mar 29, 2023K222312RayStation 12A
RaySearch Laboratories AB (PUBL), SE
MUJ
Mar 14, 2023K223279RT Elements (4.0)
Brainlab AG, DE
MUJ
Feb 23, 2023K223233Monaco RTP System
Elekta Solutions AB, SE
MUJ
Feb 2, 2023K222803Oncospace
Oncospace, Inc.
MUJ
Sep 7, 2022K220783syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
MUJ
Aug 25, 2022K211841MRI Planner
Spectronic Medical AB, SE
MUJ
Aug 22, 2022K220582ClearCalc Model RADCA V2
Radformation, Inc.
MUJ
May 17, 2022K213787Monaco RTP System
Elekta Solutions AB, SE
MUJ
Apr 15, 2022K220141RayStation 11B
RaySearch Laboratories AB (PUBL), SE
MUJ
Apr 8, 2022K212274INT Contour
Carina Medical, LLC
MUJ
Apr 5, 2022K214081MRCAT Head & Neck
Philips OY, FI
MUJ
Jan 19, 2022K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Adaptiiv, CA
MUJ
Sep 8, 2021K211867RayStation 11.0
RaySearch Laboratories AB (PUBL), SE
MUJ
Sep 2, 2021K211881AI Segmentation
Varian Medical Systems, Inc.
MUJ
Jul 30, 2021K211379syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
MUJ
Jul 1, 2021K211511decimal Bolus
.Decimal, LLC
MUJ

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