ClearanceBrief
510(k) K250440 ยท MUJ System, Planning, Radiation Therapy Treatment

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, T

ApplicantBrainlab AG, Munich, DE
DecisionSubstantially Equivalent, Jun 17, 2025
ReceivedFeb 14, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250440

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.