Data / Medical devices / Austria / Agfa HealthCare GmbH
Agfa HealthCare GmbH: FDA-registered device maker in Vienna Wien, Austria, 4 510(k) clearances
Agfa HealthCare GmbH is registered with the FDA (registration 3009238185) in Vienna Wien, Austria. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated July 3, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009238185
- Address
- Diefenbachgasse 35, Vienna Wien, Austria, 1150
- Owner or operator
- AGFA HEALTHCARE N.V. (9011611)
- Roles
- Specification developer
- First device listed
- August 15, 2011
- Registered through
- 2026
- Brand names listed
- Enterprise Imaging, Enterprise Imaging Desktops, Enterprise Imaging XERO Viewer, Enterprise Imaging XERO Viewer 8.1, XERO Viewer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 3, 2017 | K170434 | Enterprise Imaging XERO Viewer 8.1 | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| June 1, 2015 | K143397 | ICIS View | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| January 6, 2015 | K142316 | IMPAX Agility | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
| August 5, 2011 | K111945 | IMPAX NEXT GENERATION | LLZ | Substantially Equivalent | Agfa Healthcare N.V. | accessdata.fda.gov |
Compare with other makers
Updated July 3, 2017. 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.