K252708

Substantially Equivalent

Relu Cloud

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.

Applicant: Relu BV
Product code: QIH
Advisory panel: Radiology
Date received: 2025-08-27
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.