Viz LVO ContaCT
K223042Viz.ai, Inc. · cleared 2022-10-21 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Viz LVO is a combination of software modules that allow for detection and notification of patients with a suspected large vessel occlusion. Viz LVO consists of an algorithm and mobile application software module.”
Algorithmlocked, artificial intelligence machine learning (AI/ML) software algorithm
source quote (p.5)
“The Viz LVO Image Analysis Algorithm (LVO Detection Algorithm) is a locked, artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the head for a suspected large vessel occlusion (LVO).”
Adaptive (vs locked)No
source quote (p.5)
“The Viz LVO Image Analysis Algorithm (LVO Detection Algorithm) is a locked, artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the head for a suspected large vessel occlusion (LVO).”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Bench
sample size not stated
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
0
recalls in product code, 24mo
0
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). 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).