RT要素（4.5）；（要素）多発脳メトスSRS；（要素）頭蓋骨SRS；（要素）脊椎SRS；（要素）頭蓋骨SRS（コーン付き）；（要素）RT計画プラットフォーム；（要素）ドーズレビュー；（要素）再治療レビュー；（要素）セグメント[頭蓋骨、基底核、頭頸部、骨盤、脊椎、胸と脊椎、頭蓋外] RT；（要素）AI腫瘍セグメントRT；（要素）スマートブラッシュ[血管、脊椎] RT；（要素）オブジェクト管理RT

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 is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Brainlab AG. The 510(k) number is K250440.

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 received FDA 510(k) clearance on 2025-06-17, under 510(k) number K250440.

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

The FDA product code for 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 is MUJ.