Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)— 510(k) K223106
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K223106 for Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0), Substantially Equivalent on 2023-07-14. Applicant: Brainlab AG.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.