Data / Medical devices / Germany / Aycan Digitalsysteme GMBH
Aycan Digitalsysteme GMBH: FDA-registered device maker in WUERZBURG Bavaria, Germany, 2 510(k) clearances
Aycan Digitalsysteme GMBH is registered with the FDA (registration 3003895711) in WUERZBURG Bavaria, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003895711
- Address
- Innere Aumuehl Strasse 5, WUERZBURG Bavaria, Germany, 97076
- Owner or operator
- AYCAN DIGITALSYSTEME GMBH (9051337)
- Roles
- Manufacturer
- First device listed
- September 2, 2002
- Registered through
- 2026
- Brand names listed
- AYCAN X-RAY PRINT SYSTEMS, aycan OsiriX PRO, aycan mobile, aycan store, aycan workstation OsiriX PRO, aycan workstation PRO, aycan xray-print
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| September 12, 2012 | K122260 | AYCAN MOBILE | LLZ | Substantially Equivalent | Aycan Digitalsysteme GmbH | accessdata.fda.gov |
| March 17, 2011 | K103546 | AYCAN WORKSTATION OSIRIX PRO | LLZ | Substantially Equivalent | Aycan Digitalsysteme GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Device, Digital Image Storage, Radiological
Updated September 12, 2012. 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.