McKesson Cardiology

System, Image Processing, Radiological

MCKESSON ISRAEL LTD.

The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Mckesson Cardiology.

Pre-market Notification Details

Device IDK151850
510k NumberK151850
Device Name:McKesson Cardiology
ClassificationSystem, Image Processing, Radiological
Applicant MCKESSON ISRAEL LTD. HAROKMIM 26 Holon,  IL 5885849
ContactGilbert Wong
CorrespondentPaul Sumner
MCKESSON TECHNOLOGIES, INC. 5995 WINDWARD PARKWAY Alpharetta,  GA  30005
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-07
Decision Date2015-08-11
Summary:summary

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