Viz ANEURYSM, Viz ANX
K213319Viz.ai, Inc. · cleared 2022-02-18 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head.”
source quote (p.5)
“The Viz ANEURYSM Image Analysis Algorithm is an artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the head for an aneurysm.”
Validation studies (1)
Retrospective clinical
n=315 scans · 2 site(s)
endpoints: sensitivity; specificity
Reported performance (3 observations)
source quote (p.8)
“Sensitivity and specificity were 93% (83% - 98%) and 89% (85% - 93%), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and specificity. Point Estimate [95% CI] 0.93 [0.83, 0.98]”
source quote (p.8)
“Sensitivity and specificity were 93% (83% - 98%) and 89% (85% - 93%), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and specificity. Point Estimate [95% CI] 0.89 [0.85, 0.93]”
source quote (p.8)
“In addition, the area under the receiver operating characteristic curve (AUC) was 0.967 (95% CI: 0.936 -0.997), demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K221100 (decision 2022-08-29) from Viz.ai, Inc. for a matching device line ("Viz RV/LV") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221100
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).