K250440
- 510(k) number
- K250440
- Device name
- 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 DE
- Product code
- MUJ — System, Planning, Radiation Therapy Treatment
- Decision date
- 2025-06-17
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250440.pdf
Official FDA record: K250440
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.