K Number
K253269Device Name
OEC One CFDManufacturer
Date Cleared
2025-11-26
(58 days)
Regulation Number
892.1650Type
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
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N/A