FDA.report

510(k) K111989

Device
CORONIS FUSION 4MP DL
Applicant
BARCO NV
510(k) number
K111989
Product code
LLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2011-09-22
Date received
2011-07-13
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LIEVEN DE WANDEL
Address
35 President Kennedypark Kortrijk BE

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
05415334001510Coronis Fusion 4MPBarco NV2016-08-19

Legacy Summary

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FDA Review

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