VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS

Computer, Diagnostic, Programmable

MEDICAL IMAGING APPLICATIONS LLC

The following data is part of a premarket notification filed by Medical Imaging Applications Llc with the FDA for Vascular Tools 5, Consisting Of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 And Integrated Vascular Tools.

Pre-market Notification Details

Device IDK033266
510k NumberK033266
Device Name:VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS
ClassificationComputer, Diagnostic, Programmable
Applicant MEDICAL IMAGING APPLICATIONS LLC 832 FOREST HILL DR Coralville,  IA  52241
ContactMilan Sonka
CorrespondentMilan Sonka
MEDICAL IMAGING APPLICATIONS LLC 832 FOREST HILL DR Coralville,  IA  52241
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-09
Decision Date2004-12-16
Summary:summary

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