Data / Medical devices / Netherlands / Thirona BV
Thirona BV: FDA-registered device maker in Nijmegen Gelderland, Netherlands, 2 510(k) clearances
Thirona BV is registered with the FDA (registration 3014653800) in Nijmegen Gelderland, Netherlands. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014653800
- Address
- Toernooiveld 300, Nijmegen Gelderland, Netherlands, 6525 EC
- Owner or operator
- Thirona BV (10057955)
- Roles
- Manufacturer
- First device listed
- January 16, 2024
- Registered through
- 2026
- Brand names listed
- LungQ v3, LungQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| October 2, 2025 | K250766 | LungQ 4 | JAK | Substantially Equivalent | Thirona BV | accessdata.fda.gov |
| January 8, 2024 | K232412 | LungQ v3.0.0 | JAK | Substantially Equivalent | Thirona BV | accessdata.fda.gov |
Compare with other makers
Updated October 2, 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.