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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 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.

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. 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.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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