# K252708: Relu Cloud

- Pathway: 510(k) (Traditional)
- Applicant: Relu BV
- Decided: Apr 10, 2026 after 226 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Relu® Cloud is a software program for the management, transfer, and analysis of oral and maxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Source page: https://510kreport.com/device/K252708
Methodology: https://510kreport.com/methodology