FDA.report

510(k) K170476

Device
Nio Color 5.8MP (MDNC-6121)
Applicant
Barco NV
510(k) number
K170476
Product code
PGY  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-28
Date received
2017-02-16
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
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
Helena Soenen
Address
President Kennedypark 35 Kortrijk BE 8500 8500

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
05415334044043Nio 5.8MP GrayBarco NV2023-04-06
05415334044036Nio 5.8MP GrayBarco NV2023-04-06
05415334044029Nio 5.8MP ColorBarco NV2023-04-06
05415334043787Nio 5.8MP ColorBarco NV2023-04-06
05415334036895Nio 5.8MP GrayBarco NV2022-05-17
05415334036888Nio 5.8MP GrayBarco NV2022-05-17
05415334028401Nio 5.8MP GrayBarco NV2022-05-17
05415334001138Nio Color 5MPBarco NV2019-04-26
05415334001992Nio Color 3MPBarco NV2017-05-05
05415334001695Nio Color 3MPBarco NV2017-05-05
05415334000131Nio 5.8MPBarco NV2017-04-11

Legacy Summary

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FDA Review

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