FDA.report

510(k) K181080

Device
McKesson Cardiology
Applicant
Change Healthcare Israel Ltd.
510(k) number
K181080
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2018-05-24
Date received
2018-04-24
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Nadia Marchant
Address
Harokmim 26 Holon IL 5885849 5885849

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
17540262090055Change Healthcare CardiologyChange Healthcare Canada Company2021-01-28
17540262090048Change Healthcare CardiologyChange Healthcare Canada Company2020-08-23
17540262090031Change Healthcare CardiologyChange Healthcare Canada Company2019-08-26
17540262090024Change Healthcare CardiologyCHANGE HEALTHCARE ISRAEL LTD2018-11-22
17540262090017Change Healthcare CardiologyCHANGE HEALTHCARE ISRAEL LTD2018-08-20

Legacy Summary

summary

FDA Review

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