FDA.report

510(k) K242008

Device
Coronis OneLook
Applicant
Barco N.V.
510(k) number
K242008
Product code
PGY
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-02
Date received
2024-07-10
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
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
05415334046511Coronis OneLookBarco NV2024-09-30

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K233465RadiForce MX317WEizo Corporation2023-12-21
K23298524HR513CLg Electronics.Inc2023-12-11
K233693Nio Color 8MP (MDNC-8132)Barco N.V.2023-12-11