K250440

Substantially Equivalent

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

Applicant: Brainlab AG
Product code: MUJ
Advisory panel: Radiology
Date received: 2025-02-14
Decision date: 2025-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

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Data sourced from openFDA. This site is unofficial and independent of the FDA.