Data / Medical devices / Germany / Siemens Healthineers AG
Siemens Healthineers AG: FDA-registered device maker in KEMNATH Bavaria, Germany, 1 510(k) clearance
Siemens Healthineers AG is registered with the FDA (registration 3002466018) in KEMNATH Bavaria, Germany. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 4, 1978. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002466018
- Address
- Roentgenstrasse 19-21, KEMNATH Bavaria, Germany, 95478
- Owner or operator
- Siemens Healthineers AG (8010024)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- September 12, 2005
- Registered through
- 2027
- Brand names listed
- ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE), Arcadis Avantic, Arcadis Varic, Bucky Wall Stand Family, CIARTIC Move (VB10), Cios Alpha, Cios Alpha (SW VA30), Cios Alpha (VA30G) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Beam Limiting, X-Ray, Diagnostic | KPW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | 1 | Manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Contract manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Contract manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Contract manufacturer | accessdata.fda.gov |
| Table, Radiologic | KXJ | 2 | Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | 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 |
|---|---|---|---|---|---|---|
| December 4, 1978 | K781984 | COLLIMATOR, HEART CONTOUR | KPW | Substantially Equivalent | Siemens Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of Holder, Radiographic Cassette, Wall-Mounted
- All makers of Tube Mount, X-Ray, Diagnostic
- All makers of Device, Beam Limiting, X-Ray, Diagnostic
Updated December 4, 1978. 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.