K243633
- 510(k) number
- K243633
- Device name
- Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
- Applicant
- Brainlab AG DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-06-13
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243633.pdf
Official FDA record: K243633
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.