K-number	K252708
Device name	Relu Cloud
Applicant	Relu BV
Product code	QIH
Device class	Class II
Decision date	Apr 10, 2026
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Relu® Cloud is a software program for managing, transferring, and analyzing oral and maxillofacial image information. It displays and enhances digital images from various sources to support diagnostic and treatment planning processes, and stores/provides images within the system or across different computer locations.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), 8.5.2 (Corrective action), and 8.5.3 (Preventative action).

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Relu Cloud

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