Relu Cloud— 510(k) K252708

Name: FDA 510(k) clearance K252708
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Relu BV

FDA 510(k) clearance K252708 for Relu Cloud, Substantially Equivalent on 2026-04-10. Applicant: Relu BV. Device class: 2.

Summary

Relu Cloud is filed under QIH, automated radiological image processing software. Relu is a Belgian company that builds AI for dental and maxillofacial imaging, especially automated segmentation of CBCT scans. "Cloud" points to a hosted version of that software.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Relu BV filed from Leuven, Belgium. Review took 226 days (August 27, 2025 to April 10, 2026). Hosted imaging software gets a close cybersecurity review, since patient images leave the clinic.

Clearance details

Applicant: Relu BV
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
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 ↗

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