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510(k) Data Aggregation
K Number
K052023Device Name
CADIMAS VERSION 1.0
Manufacturer
Date Cleared
2005-12-08
(135 days)
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
**ALAN PENN **& ASSOCIATES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.
Device Description
CADimas V1.0™ is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. CADimas™ supports evaluation of dynamic MRI data acquired during contrast administration. CADimas™ segments and labels tissue types based on kinetic and margin characteristics of enhancement patterns (parametric image maps), and performs other user-defined post-processing functions (image subtractions. multiplanar reformats).
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