K243633

Substantially Equivalent

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: QIH
Advisory panel: Radiology
Date received: 2024-11-25
Decision date: 2025-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

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