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510(k) Data Aggregation
K Number
K003639Device Name
VITREA 2 CT PERFUSION OPTIONManufacturer
Date Cleared
2001-01-23
(60 days)
Product Code
Regulation Number
892.1750Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
VITREA 2 CT PERFUSION OPTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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