K232759
- 510(k) number
- K232759
- 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
- 2024-05-21
- Date received
- 2023-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232759.pdf
Official FDA record: K232759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.