CARDIAC VX

System, Image Processing, Radiological

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Cardiac Vx.

Pre-market Notification Details

Device IDK121762
510k NumberK121762
Device Name:CARDIAC VX
ClassificationSystem, Image Processing, Radiological
Applicant GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
ContactMichelle Huettner
CorrespondentMichelle Huettner
GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha,  WI  53188
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-15
Decision Date2013-01-18
Summary:summary

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