McKesson Cardiology

System, Image Processing, Radiological

Change Healthcare Israel Ltd.

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

Pre-market Notification Details

Device IDK181080
510k NumberK181080
Device Name:McKesson Cardiology
ClassificationSystem, Image Processing, Radiological
Applicant Change Healthcare Israel Ltd. HaRokmim 26 Holon,  IL 5885849
ContactNadia Marchant
CorrespondentPaul Sumner
Change Healthcare Technologies LLC 5995 Windward Parkway Alpharetta,  GA  30005
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-24
Decision Date2018-05-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17540262090024 K181080 000
17540262090017 K181080 000
17540262090048 K181080 000
17540262090055 K181080 000
17540262090031 K181080 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.