Viz ANEURYSM, Viz ANX

K213319

Viz.ai, Inc. · cleared 2022-02-18 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
Algorithmartificial intelligence machine learning (AI/ML) software algorithm
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.”
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=315 scans · 2 site(s)

endpoints: Sensitivity; Specificity; AUC

Reported performance (3 observations)

sensitivity0.93CI [0.83, 0.98]
source quote (p.8)
“Sensitivity (Positives = 67) Point Estimate [95% CI] 0.93 [0.83, 0.98]”
specificity0.89CI [0.85, 0.93]
source quote (p.8)
“Specificity (Negatives = 248) Point Estimate [95% CI] 0.89 [0.85, 0.93]”
aurocas written: “auc”0.967CI [0.936 -0.997]
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213319