Data / Medical devices / Belgium / Relu BV
Relu BV: FDA-registered device maker in Leuven Antwerpen, Belgium, 2 510(k) clearances
Relu BV is registered with the FDA (registration 3031915908) in Leuven Antwerpen, Belgium. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031915908
- Address
- Kolonel Begaultlaan 1A/51, Leuven Antwerpen, Belgium, 3012
- Owner or operator
- Relu BV (10091216)
- Roles
- Manufacturer
- First device listed
- July 25, 2024
- Registered through
- 2026
- Brand names listed
- Relu Cloud, Relu Creator, Relu Engine
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 |
|---|---|---|---|---|---|---|
| April 10, 2026 | K252708 | Relu Cloud | QIH | Substantially Equivalent | Relu BV | accessdata.fda.gov |
| June 13, 2024 | K233925 | Relu Creator | QIH | Substantially Equivalent | Relu BV | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2026. 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.