FDA Clearance
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
- Submission
- K250440
- Type
- 510(k)
- Company
- Brainlab AG
- Decision Date
- Jun 17, 2025
- Specialty
- Radiology
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Source: https://healthaicentral.com/research/fda-clearances/K250440