Device Name
Allix5Manufacturer
Date Cleared
2025-05-30
(266 days)
Product Code
Regulation Number
892.8500Type
DirectPanel
RadiologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A