Data / Medical devices / System, X-Ray, Tomography, Computed / Germany
FDA-registered makers of System, X-Ray, Tomography, Computed in Germany: 6 establishments
6 establishments in Germany are registered with the FDA to make System, X-Ray, Tomography, Computed (product code JAK). 6 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
- System, X-Ray, Tomography, Computed
- Product code
- JAK
- Country
- Germany
Makers of System, X-Ray, Tomography, Computed in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Complaint file establishment, Manufacturer | 124 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Manufacturer | 4 | March 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Exporter to the US, Manufacturer | 3 | March 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| iSYS Medizintechnik GmbH | Untermeitingen Bavaria, Germany | Manufacturer | 2 | October 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Mevis Medical Solutions AG | Bremen, Germany | Manufacturer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG Varian Cancer Therapy (CTH) | Erlangen Bavaria, Germany | Manufacturer | 1 | March 8, 2018 | 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.