Data Analysis Facilitation Suite (DAFS)— 510(k) K253944

Name: FDA 510(k) clearance K253944
Creator: U.S. Food and Drug Administration
Published: 2026-03-16

Substantially Equivalent

Voronoi Health Analytics Incorporated

FDA 510(k) clearance K253944 for Data Analysis Facilitation Suite (DAFS), Substantially Equivalent on 2026-03-16. Applicant: Voronoi Health Analytics Incorporated. Device class: 2.

Clearance details

Applicant: Voronoi Health Analytics Incorporated
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-10
Decision date: 2026-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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