510(k) K252708

Device: Relu Cloud
Applicant: Relu BV
510(k) number: K252708
Product code: QIH
Decision: Substantially Equivalent (SESE)
Decision date: 2026-04-10
Date received: 2025-08-27
Regulation: 892.2050
Classification name: Automated Radiological Image Processing Software
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: N
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: Holger Willems
Address: Kolonel Begaultlaan 1a/51 Leuven BE 3012 3012

FDA Registration Numbers

3018302800
3025602618
3009731198
3023217364
9710602
3035950510
3032109181
3008007310
3025110425
3001722928
3006985147
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8043836

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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