Data / Medical devices / Austria / Piur Imaging GMBH
Piur Imaging GMBH: FDA-registered device maker in Vienna Wien, Austria, 2 510(k) clearances
Piur Imaging GMBH is registered with the FDA (registration 3020928588) in Vienna Wien, Austria. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020928588
- Address
- Kaiserstrasse 8/1/11, Vienna Wien, Austria, 1070
- Owner or operator
- PIUR IMAGING GmbH (10091767)
- Roles
- Manufacturer
- First device listed
- October 31, 2024
- Registered through
- 2027
- Brand names listed
- PIUR tUS Infinity, PIUR tUS inside
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| June 30, 2025 | K250484 | PIUR tUS inside | QIH | Substantially Equivalent | Piur Imaging GmbH | accessdata.fda.gov |
| September 20, 2024 | K240036 | PIUR tUS Infinity | QIH | Substantially Equivalent | Piur Imaging GmbH | accessdata.fda.gov |
Compare with other makers
Updated June 30, 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.