K Number
K002100Device Name
XIMX SYSTEMManufacturer
Date Cleared
2000-08-25
(45 days)
Product Code
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A