# K253944: Data Analysis Facilitation Suite (DAFS)

- Pathway: 510(k) (Traditional)
- Applicant: Voronoi Health Analytics Incorporated
- Decided: Mar 16, 2026 after 96 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954355 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223556: DeepCatch, Medical IP Co., Ltd. (2023) Summary page 5.

## Indications for use
OAFS is a software-only medical device intended for use by trained healthcare professionals for the automated segmentation, visualization, and quantitative analysis of anatomical structures in computed tomography (CT) images. The software processes DICOM Part 10 formatted CT image data to identify, segment anatomical structures, including body composition tissues and internal organs and annotate DICOM slices by anatomical landmarks. The device provides quantitative measurements of these structures, including area, volume, and intensity values, and displays 2D and 3D visual representations. The software provides tools for visualization, review, and manual editing of segmentation and slice annotation results and associated measurements. OAFS is intended for use as an adjunct to clinical assessment. The device does not provide diagnostic interpretation, and all results must be reviewed and confirmed by a qualified healthcare professional.

Source page: https://510kreport.com/device/K253944
Methodology: https://510kreport.com/methodology