Relu Cloud— 510(k) K252708
Substantially EquivalentRelu BV
FDA 510(k) clearance K252708 for Relu Cloud, Substantially Equivalent on 2026-04-10. Applicant: Relu BV.
Summary
Relu Cloud is a radiology software product from Relu BV, a Belgian developer focused on AI-driven dental and maxillofacial image analysis. Product code QIH — radiological image management / PACS-adjacent software — typically covers viewing, storage, and analytic workflows rather than detection algorithms.
Radiology panel, Traditional 510(k). "Cloud" in the name signals a hosted deployment model, which introduces cybersecurity and patient-data handling questions during FDA review — recent QIH submissions routinely include cybersecurity documentation as a standard part of the filing.
Relu is based in Leuven, Belgium, historically associated with dental CBCT workflows. Eight-month review. Cloud-deployed radiology software is an expanding corner of QIH as practices move away from on-premise PACS.
Clearance details
- Applicant
- Relu BV
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Data sourced from openFDA. This site is unofficial and independent of the FDA.