Viz AAA
K223443Viz. ai, Inc. · cleared 2023-03-17 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm.”
Algorithmartificial intelligence machine learning (AI/ML) software algorithm
source quote (p.5)
“The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=466 scans · 2 site(s)
endpoints: sensitivity; specificity; AUC
Reported performance (3 observations)
sensitivity0.96CI [0.92, 0.98]
source quote (p.9)
“Sensitivity and specificity were reported to be 96% [0.92, 0.98] and 95% [0.92, 0.97], respectively.”
specificity0.95CI [0.92, 0.97]
source quote (p.9)
“Sensitivity and specificity were reported to be 96% [0.92, 0.98] and 95% [0.92, 0.97], respectively.”
aurocas written: “auc”0.99CI [0.98 - 1.00]
source quote (p.9)
“The area under the receiver operating characteristic curve (AUC) was reported as 0.99 [0.98 - 1.00], 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
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).