AI-CVD
K252029HeartLung Corporation · cleared 2025-12-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.12)
“Not applicable for this software as a medical device.”
source quote (p.7)
“AI-CVD® is a multi-module deep learning-based software platform developed to automatically segment and quantify a broad range of cardiovascular, pulmonary, musculoskeletal, and metabolic biomarkers from standard chest or whole-body CT scans.”
Validation studies (1)
Retrospective clinical
n=913 scans · 3 site(s)
endpoints: comparative safety and effectiveness between expert manual measurements and both the automated Agatston CAC scores and the AI-derived relative density-based calcium scores
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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).