K Number
K252041Device Name
Fibresolve (with PCCP)Manufacturer
Date Cleared
2025-11-07
(130 days)
Product Code
Regulation Number
892.2085Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Loading...
N/A