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FDA 510(k)

Data Analysis Facilitation Suite (DAFS)

K-Number: K253944 · 2026-03-16

ApplicantVoronoi Health Analytics Incorporated
Decision Date2026-03-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Data Analysis Facilitation Suite (DAFS) is a medical device manufactured by Voronoi Health Analytics Incorporated. It received FDA 510(k) clearance on 2026-03-16 under approval number K253944. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Data Analysis Facilitation Suite (DAFS)?

Data Analysis Facilitation Suite (DAFS) is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Voronoi Health Analytics Incorporated. The 510(k) number is K253944.

When was Data Analysis Facilitation Suite (DAFS) approved by the FDA?

Data Analysis Facilitation Suite (DAFS) received FDA 510(k) clearance on 2026-03-16, under approval number K253944.

What company makes Data Analysis Facilitation Suite (DAFS)?

Data Analysis Facilitation Suite (DAFS) is manufactured by Voronoi Health Analytics Incorporated.

What is the FDA product code for Data Analysis Facilitation Suite (DAFS)?

The FDA product code for Data Analysis Facilitation Suite (DAFS) is QIH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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