MUJ — System, Planning, Radiation Therapy Treatment Class II

FDA Device Classification

Classification Details

Product Code
MUJ
Device Class
Class II
Regulation Number
892.5050
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252002elekta solutionsMonaco RTP System (6.3)February 19, 2026
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K253091therapanaceaART-Plan+ (v3.1.0)December 23, 2025
K252109raysearch laboratories ab (publ)RayStation (2024A SP3)December 22, 2025
K252863radformationClearCalc Model RADCA V2.6December 19, 2025
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K250440brainlabRT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; June 17, 2025
K242992raysearch laboratories ab (publ)RayCare (2024A SP1)April 17, 2025
K242748oncospaceOncospaceApril 11, 2025
K240398raysearch laboratories ab (publ)RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 202April 4, 2025
K242822therapanaceaART-Plan+ (v.3.0.0)February 25, 2025
K242463varian medical systemsARIA Radiation Therapy Management System (18.1)December 13, 2024
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