AV Vascular

K253735

Philips Medical Systems Nederland B.V. · cleared 2026-01-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“AV Vascular is a post-processing software application intended for visualization, assessment, and quantification of vessels in computed tomography angiography (CTA) and magnetic resonance angiography (MRA) data with a unified workflow for both modalities.”
Algorithmmodel-based algorithm, AI-based algorithm
source quote (p.6)
“Performance testing was conducted for subclavian artery extraction on body cases (model-based algorithm), aorto-iliac wall segmentation (AI-based algorithm) and ring marker placement (model-based algorithm).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=80 patients · 11 site(s)

endpoints: Dice similarity coefficient (DSC); mean surface distance (MSD); Hausdorff distance (HD); measurement accuracy (minimum and maximum diameter, Dmin and Dmax)

Reported performance (2 observations)

diceas written: “DSC 3D”0.96CI 0.96, 0.97
source quote (p.7)
“DSC 3D DSC > 0.9 0.96 (0.96, 0.97)”
diceas written: “DSC 2D”0.96CI 0.95, 0.96
source quote (p.7)
“2D DSC > 0.9 0.96 (0.95, 0.96)”

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
1
drift signals on this device
  • predicate_cohort_contagion

    K253735 shares predicate K150665 with K260169 (AV Cardiac CT), whose product code JAK recorded 75 recall event(s) in the trailing 24 months.

    first seen 2026-07-08 · predicate:K150665 sibling:K260169

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/K253735