AV Vascular
K253735Philips Medical Systems Nederland B.V. · cleared 2026-01-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
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).”
Validation studies (3)
Standalone
sample size not stated
endpoints: subclavian artery centerline extraction
Standalone
sample size not stated
endpoints: clinical acceptability without any adjustment
Standalone
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)
source quote (p.7)
“DSC 3D DSC > 0.9 0.96 (0.96, 0.97)”
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
- 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). 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).