Data / Medical devices / Automated Radiological Image Processing Software / Netherlands
FDA-registered makers of Automated Radiological Image Processing Software in the Netherlands: 8 establishments
8 establishments in the Netherlands are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 6 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
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Netherlands
Makers of Automated Radiological Image Processing Software in the Netherlands
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Augmedit | Naarden Noord-Holland, Netherlands | Manufacturer | 1 | September 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medicalvr BV | Nieuw-Vennep Noord-Holland, Netherlands | Manufacturer | 1 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mriguidance B.V. | Utrecht, Netherlands | Manufacturer | 1 | March 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 1 | March 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Pie Medical Imaging B.V. | MAASTRICHT Limburg, Netherlands | Manufacturer | 1 | November 3, 2025 | 0 | 1 | 0 | api.fda.gov |
| Screenpoint Medical | Nijmegen Gelderland, Netherlands | Complaint file establishment, Manufacturer | 1 | December 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proton B.V. | GM Sittard Limburg, Netherlands | Contract manufacturer, 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.