510(k) K170837
- Device
- Nio Color 3MP (MDNC-3421)
- Applicant
- Barco NV
- 510(k) number
- K170837
- Product code
- PGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-05
- Date received
- 2017-03-21
- 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
- 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
- 3010043098
- 3007817002
- 3004082357
- 3024137003
- 3003032840
- 9613188
- 3024689474
- 3002808157
- 3016696283
- 3024897454
- 1000207387
- 3013084615
- 3004434200
- 3008481104
- 1000181154
- 3013501671
- 3009553444
- 3015976667
- 3006615210
- 3031232523
- 3000237660
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415334028326 | Nio Color 3MP | Barco NV | 2023-09-26 |
| 05415334001916 | Nio Color 3MP | Barco NV | 2017-04-11 |
| 05415334001688 | Nio Color 3MP | Barco NV | 2017-04-11 |
Legacy Summary
summary
FDA Review
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