FDA.report

510(k) K151850

Device
McKesson Cardiology
Applicant
MCKESSON ISRAEL LTD.
510(k) number
K151850
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-08-11
Date received
2015-07-07
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
GILBERT WONG
Address
Harokmim 26 Holon IL 5885849 5885849

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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