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

Brainlab AG · K250440 · 2025-06-17

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 an AI-enabled medical device from Brainlab AG, listed by FDA (510(k), K250440) with a decision date of 2025-06-17. Review panel: Radiology.

FDA submission numberK250440
Pathway510(k)
CompanyBrainlab AG
Review panel (specialty)Radiology
FDA decision date2025-06-17
DecisionSubstantially Equivalent
Product codeMUJ
ClassificationSystem, Planning, Radiation Therapy Treatment
Device class2
Regulation number892.5050
Review time (calendar days)123
Applicant countryDE

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.