K Number
DEN250002Device Name
Delphi-MD SystemManufacturer
Date Cleared
2025-08-20
(229 days)
Product Code
Regulation Number
882.1860Type
DirectPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A