Data / Medical devices / System, Image Processing, Radiological / Netherlands
FDA-registered makers of System, Image Processing, Radiological in the Netherlands: 10 establishments
10 establishments in the Netherlands are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- Netherlands
Makers of System, Image Processing, Radiological in the Netherlands
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Pie Medical Imaging B.V. | MAASTRICHT Limburg, Netherlands | Manufacturer | 6 | February 1, 2024 | 0 | 1 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 5 | May 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medis Medical Imaging Systems, B.V. | LEIDEN Zuid-Holland, Netherlands | Manufacturer | 3 | January 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | Eindhoven Noord-Brabant, Netherlands | Complaint file establishment, Exporter to the US, Manufacturer | 3 | October 2, 2025 | 0 | 3 | 0 | api.fda.gov |
| NICo-Lab B.V. | Amsterdam Noord-Holland, Netherlands | Manufacturer | 1 | December 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | Best Noord-Brabant, Netherlands | Specification developer | 1 | May 1, 2006 | 0 | 0 | 0 | api.fda.gov |
| Augmedit | Naarden Noord-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demcon Production B.V. | Enschede Overijssel, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| QFR Solutions BV | Leiden Zuid-Holland, Netherlands | Manufacturer | 0 | 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.