Device Name
Modius LeanManufacturer
Date Cleared
2025-10-17
(303 days)
Product Code
Regulation Number
876.5984Type
DirectReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A