FDA 510(k)

Data Analysis Facilitation Suite (DAFS)

N.º K: K253944 · 2026-03-16

SolicitanteVoronoi Health Analytics Incorporated

Fecha de decisión2026-03-16

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Voronoi Health Analytics Incorporated. The 510(k) number is K253944.

When did Data Analysis Facilitation Suite (DAFS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Data Analysis Facilitation Suite (DAFS)?

The FDA 510(k) record lists Voronoi Health Analytics Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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Fuente oficial

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