Data Analysis Facilitation Suite (DAFS)

K253944

Voronoi Health Analytics Incorporated · cleared 2026-03-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmartificial intelligence (AI) algorithms
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).”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=124 patients

endpoints: slice-level positional differences between automated landmarks and the reference standard; Dice Similarity Coefficient (DSC) across the anatomical structures supported by the device

Reported performance (1 observation)

diceas written: “mean Dice scores”stated without valueCI >0.90
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253944