Data / Medical devices / Germany / Ziehm Imaging GMBH
Ziehm Imaging GMBH: FDA-registered device maker in Nuernberg, Bavaria, Germany, 4 510(k) clearances
Ziehm Imaging GMBH is registered with the FDA (registration 9681146) in Nuernberg, Bavaria, Germany. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681146
- FEI number
- 3005430103
- Address
- Lina-Ammon-Strasse 10 --, Nuernberg, Bavaria, Germany, 90471
- Owner or operator
- ZIEHM IMAGING GMBH (9019776)
- Roles
- Manufacturer
- First device listed
- February 28, 2025
- Registered through
- 2026
- Brand names listed
- Ziehm Solo FD, Ziehm Vision FD, Ziehm Vision RFD, Ziehm Vision RFD 3D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2025 | K243646 | Ziehm Solo FD | OWB | Substantially Equivalent | Ziehm Imaging GmbH | accessdata.fda.gov |
| March 13, 2025 | K243735 | Ziehm Vision FD | OWB | Substantially Equivalent | Ziehm Imaging GmbH | accessdata.fda.gov |
| January 21, 2025 | K243303 | Ziehm Vision RFD 3D | OWB | Substantially Equivalent | Ziehm Imaging GmbH | accessdata.fda.gov |
| January 15, 2025 | K243328 | Ziehm Vision RFD | OWB | Substantially Equivalent | Ziehm Imaging GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
Updated March 17, 2025. 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.