Device Listing 1899343421

Listing Summary#

Listing key
1899343421
Premarket submission
K243633
Device
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
Decision date
2025-06-13