ALT-006296K243633Green Status
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)
Brainlab AG ยท Manufacturer
All identifiers (2)
Aletia (canonical)
ALT-006296FDA 510(k) ยท US (primary)
K243633Overview
Accountability Tier
Tier 2
Regulatory Registrations
๐
US
FDA
ID: K243633
510k
Lifecycle Signals
Last Automated Sync
Jun 2026
Last Clinical Review
Not reviewed
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