Data / Medical devices / Belgium / Agfa HealthCare
Agfa HealthCare: FDA-registered device maker in Gent West-Vlaanderen, Belgium, 2 510(k) clearances
Agfa HealthCare is registered with the FDA (registration 3009238175) in Gent West-Vlaanderen, Belgium. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 6, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009238175
- Address
- Moutstraat 100, Gent West-Vlaanderen, Belgium, B-9000
- Owner or operator
- AGFA HEALTHCARE N.V. (9011611)
- Roles
- Specification developer
- First device listed
- August 15, 2011
- Registered through
- 2026
- Brand names listed
- Enterprise Imaging Desktops
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 6, 2015 | K142316 | IMPAX Agility | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 5, 2011 | K111945 | IMPAX NEXT GENERATION | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2015. 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.