Data / Medical devices / System, Image Processing, Radiological / Belgium
FDA-registered makers of System, Image Processing, Radiological in Belgium: 8 establishments
8 establishments in Belgium are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- Belgium
Makers of System, Image Processing, Radiological in Belgium
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Agfa Healthcare N.V. | MORTSEL Antwerpen, Belgium | Complaint file establishment, Manufacturer, Specification developer | 14 | July 3, 2017 | 0 | 3 | 0 | api.fda.gov |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 13 | March 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare c/o Medicim NV | Mechelen Antwerpen, Belgium | Complaint file establishment, Manufacturer | 7 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| icometrix | Leuven Vlaams Brabant, Belgium | Manufacturer | 5 | February 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Barco N.V. | KORTRIJK West-Vlaanderen, Belgium | Exporter to the US, Manufacturer, Specification developer | 3 | April 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Agfa HealthCare | Gent West-Vlaanderen, Belgium | Specification developer | 2 | January 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY Implants N.V. | Hasselt Limburg, Belgium | Manufacturer | 2 | April 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Agfa N.V. | Mortsel Antwerpen, Belgium | Complaint file establishment, Manufacturer, Specification developer | 1 | June 22, 2007 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.