Artificial Intelligence Renal Assessment (AIRA) Version 1— 510(k) K261677

Name: FDA 510(k) clearance K261677
Creator: U.S. Food and Drug Administration
Published: 2026-09-15

Substantially Equivalent

Aramis Global AI Consultancies, LLC

FDA 510(k) clearance K261677 for Artificial Intelligence Renal Assessment (AIRA) Version 1, Substantially Equivalent on 2026-09-15. Applicant: Aramis Global AI Consultancies, LLC. Device class: 2.

Clearance details

Applicant: Aramis Global AI Consultancies, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-21
Decision date: 2026-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dubai, AE

Download summary PDF View on FDA.gov ↗

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