ALT-001005DEN210035Amber Status
Hologic, Inc.
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
All identifiers (2)
Aletia (canonical)
ALT-001005FDA De Novo · US (primary)
DEN210035Overview
Accountability Tier
Tier 2
Regulatory Registrations
🌐
US
FDA
ID: DEN210035
510k
Lifecycle Signals
Last Automated Sync
Mar 2026
Last Clinical Review
Not reviewed
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