K Number
DEN240068Device Name
ArteraAI ProstateManufacturer
Date Cleared
2025-07-31
(248 days)
Product Code
Regulation Number
864.3755Type
DirectPanel
PAReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A