Data / Medical devices / Netherlands / QFR Solutions BV
QFR Solutions BV: FDA-registered device maker in Leiden Zuid-Holland, Netherlands, 1 510(k) clearance
QFR Solutions BV is registered with the FDA (registration 3038136528) in Leiden Zuid-Holland, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2025. 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
- 3038136528
- Address
- Schuttersveld 9, Leiden Zuid-Holland, Netherlands, 2316 XG
- Owner or operator
- QFR Solutions bv (10090409)
- Roles
- Manufacturer
- First device listed
- April 11, 2025
- Registered through
- 2026
- Brand names listed
- QFR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | QHA | 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 |
|---|---|---|---|---|---|---|
| April 4, 2025 | K243769 | QFR (3.0) | QHA | Substantially Equivalent | Qfr Solutions BV | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Updated April 4, 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.