STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE

System, Image Processing, Radiological

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthviz Advanced Planning Application With Stealthdti Package.

Pre-market Notification Details

Device IDK081512
510k NumberK081512
Device Name:STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
ClassificationSystem, Image Processing, Radiological
Applicant MEDTRONIC NAVIGATION, INC. 3025 PERRY STREET Denver,  CO  80212
ContactKevin Morningstar
CorrespondentKevin Morningstar
MEDTRONIC NAVIGATION, INC. 3025 PERRY STREET Denver,  CO  80212
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-30
Decision Date2008-07-18
Summary:summary

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