Device Name
ArteraAI ProstateManufacturer
Date Cleared
2025-07-31
(248 days)
Product Code
Regulation Number
864.3755Type
DirectPanel
PathologyAge 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