Data / Medical devices / United States / Barco Inc Portland
Barco Inc Portland: FDA-registered device maker in Portland, OR, United States, 1 510(k) clearance
Barco Inc Portland is registered with the FDA (registration 3024689474) in Portland, OR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 6, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024689474
- Address
- 735 SW 20th Place, Suite 100, Portland, OR, United States, 97205
- Owner or operator
- BARCO NV (9031117)
- Roles
- Manufacturer
- First device listed
- September 17, 2019
- Registered through
- 2027
- Brand names listed
- Coronis Fusion 4MP, Coronis Fusion 6MP, Intuitive Workflow Tools (IWT), MDCC-4430, MDCC-6530
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2019 | K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | PGY | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.