Brainlab Elements (7.0) +5 more— 510(k) K243633
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K243633 for Brainlab Elements (7.0) +5 more, Substantially Equivalent on 2025-06-13. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Device name as filed
- 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
- 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
Recent devices under product code QIH
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