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510(k) Data Aggregation
K Number
K000315Device Name
VENTRICULAR ANALYSIS TOOLKIT OPTIONManufacturer
Date Cleared
2000-03-27
(55 days)
Product Code
Regulation Number
892.1000Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
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Device Name :
VENTRICULAR ANALYSIS TOOLKIT OPTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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