K252476
- 510(k) number
- K252476
- Device name
- Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- Applicant
- Brainlab AG DE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-10-16
- Date received
- 2025-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.2 MB · U.S. public domain
Also available from FDA: K252476.pdf
Official FDA record: K252476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.