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Data Analysis Facilitation Suite (DAFS)

by Voronoi Health Analytics Incorporated 510(k)

Active United States

510(k) K253944

Overview

The Data Analysis Facilitation Suite (DAFS) is a radiology software platform designed for automated segmentation and analysis of CT and PET imaging data. It processes high-dimensional medical imaging to generate clear, actionable insights, reducing manual workload and improving diagnostic precision.

DAFS is supplied as a software solution for radiology workflows and has received FDA 510(k) clearance under the Radiology advisory committee. The product is intended for use in clinical settings where automated analysis of imaging data is required, with no indication of single-use or reusable status. It is regulated under product code QIH and carries the K-number K253944.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253944 Date16 Mar 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Questions

  • What types of medical imaging does the Data Analysis Facilitation Suite (DAFS) support for automated analysis?

    DAFS is specifically designed to process CT (computed tomography) and PET (positron emission tomography) imaging data. It automates segmentation and analysis of these modalities to generate clear, actionable insights, reducing the need for manual review and improving diagnostic accuracy in radiology workflows.

  • How is the Data Analysis Facilitation Suite (DAFS) supplied, and is it intended for single-use or reusable applications?

    DAFS is supplied as a software solution for integration into radiology workflows. Unlike physical medical devices, it is not classified as single-use or reusable—its functionality is tied to the software platform itself, which can be deployed and utilized repeatedly in clinical settings without consumable replacements.

  • What regulatory pathway did Voronoi Health Analytics Incorporated follow to obtain clearance for DAFS, and what does this mean for its use?

    DAFS received FDA 510(k) clearance under the Radiology advisory committee (RA), classified as *substantially equivalent* (SESE) to a predicate device. This means the FDA determined it meets the same performance standards as existing automated imaging analysis tools, allowing its use in clinical settings where automated CT and PET data analysis is required. The product code QIH and K-number K253944 further identify its regulatory classification.

  • Can DAFS be integrated into existing hospital or clinic radiology systems, or is it a standalone solution?

    DAFS is designed as a software platform intended for integration into radiology workflows, implying compatibility with existing hospital or clinic systems. While the exact integration requirements aren’t detailed, its purpose is to streamline automated segmentation and analysis of CT/PET data within clinical environments, suggesting it is built to interface with radiology IT infrastructure rather than operating as a standalone tool.