Data Analysis Facilitation Suite (DAFS)
K253944Voronoi Health Analytics Incorporated · cleared 2026-03-16 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“DAFS 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.”
source quote (p.6)
“The performance of the DAFS artificial intelligence (AI) algorithms was evaluated using an independent internal testing dataset derived from multi-institutional CT studies curated by The Cancer Imaging Archive (TCIA).”
Validation studies (1)
Standalone
n=124 patients
endpoints: Vertebral annotation accuracy assessed by measuring slice-level positional differences between automated landmarks and the reference standard; Segmentation performance evaluated using the Dice Similarity Coefficient (DSC) across the anatomical structures supported by the device
Reported performance (1 observation)
source quote (p.6)
“Overall, the algorithms demonstrated high agreement with the reference standard, with most major anatomical structures achieving mean Dice scores greater than 0.90.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).