Brainlab Elements Image Fusion, Contouring (4.5) +4 more— 510(k) K223106
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K223106 for Brainlab Elements Image Fusion, Contouring (4.5) +4 more, Substantially Equivalent on 2023-07-14. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Device name as filed
- Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
- Applicant
- Brainlab AG
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
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