FDA.report

510(k) K191845

Device
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
Applicant
Barco NV
510(k) number
K191845
Product code
PGY  
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-06
Date received
2019-07-10
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
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
Julie Vandecandelaere
Address
President Kennedypark 35 Kortrijk BE 8500 8500

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
05415334034785Coronis Fusion 4 MPBarco NV2022-05-24
05415334034914Coronis Fusion 6MPBarco NV2022-05-17
05415334034792Coronis Fusion 6MPBarco NV2022-05-17
05415334034778Coronis Fusion 4MPBarco NV2022-05-17
05415334034754Coronis Fusion 4MPBarco NV2022-05-17
05415334028845Coronis Fusion 4 MPBarco NV2020-07-23
05415334025981Coronis Fusion 4 MPBarco NV2020-07-23
05415334025974Coronis Fusion 6 MPBarco NV2020-07-23
05415334002050Intuitive Workflow ToolsBarco NV2020-07-23
05415334002340Coronis Fusion 4 MPBarco NV2019-10-15
05415334002326Coronis Fusion 6 MPBarco NV2019-10-15

Legacy Summary

summary

FDA Review

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