Data / Medical devices / Automated Radiological Image Processing Software / Germany
FDA-registered makers of Automated Radiological Image Processing Software in Germany: 7 establishments
7 establishments in Germany are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Germany
Makers of Automated Radiological Image Processing Software in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Manufacturer | 6 | June 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Manufacturer | 5 | September 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Manufacturer | 2 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| TOMTEC Imaging Systems GMBH | UNTERSCHLEISSHEIM Bavaria, Germany | Manufacturer, Specification developer | 2 | February 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Durr Dental Se | Bietigheim-Bissingen Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | August 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Metamorphosis GMBH | Paderborn North Rhine-Westphalia, Germany | Complaint file establishment, Manufacturer | 1 | October 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Visage Imaging GmbH | Berlin, Germany | Manufacturer | 1 | January 29, 2021 | 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.