ALT-001054K223491Amber Status
Ge Medical Systems, LLC
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
All identifiers (2)
Aletia (canonical)
ALT-001054FDA 510(k) ยท US (primary)
K223491Overview
Accountability Tier
Tier 2
Regulatory Registrations
๐
US
FDA
ID: K223491
510k
Lifecycle Signals
Last Automated Sync
Mar 2026
Last Clinical Review
Not reviewed
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