FDA.report

510(k) K112720

Device
MCKESSON HORIZON CARDIOLOGY
Applicant
MCKESSON ISRAEL LTD.
510(k) number
K112720
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-01-30
Date received
2011-09-19
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
TOMER LEVY
Address
Hanechoshet 4 Tel Aviv IL 69710 69710

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
80010939070025McKesson CardiologyMCKESSON TECHNOLOGIES INC.2017-03-09

Legacy Summary

summary

FDA Review

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