Data / Medical devices / Austria / Ib Lab GMBH
Ib Lab GMBH: FDA-registered device maker in Vienna Wien, Austria, 2 510(k) clearances
Ib Lab GMBH is registered with the FDA (registration 3016965352) in Vienna Wien, Austria. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016965352
- Address
- Zehetnergasse 6/2/2, Vienna Wien, Austria, 1140
- Owner or operator
- IB Lab GmbH (10074574)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- May 27, 2020
- Registered through
- 2026
- Brand names listed
- IB Lab LAMA, KOALA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Exporter to the US, 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 16, 2023 | K223646 | IB Lab LAMA | QIH | Substantially Equivalent | Ib Lab GmbH | accessdata.fda.gov |
| November 5, 2019 | K192109 | KOALA | LLZ | Substantially Equivalent | Ib Lab GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
Updated June 16, 2023. 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.