510(k) Report

FDA applicant

Viz.Al, Inc.

San Francisco, CA1 decision2018–20180 recalls

FDA records 1 decision for Viz.Al, Inc. (San Francisco, CA) in 2018: 1 De Novo grant. All are in product code QAS (Radiological Computer-Assisted Triage And…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Viz.Al, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Viz.Al, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QASRadiological Computer-Assisted Triage And Notification Software1decision

Who builds on its devices?

Later devices cite its devices 10 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170073ContaCTViz.Al, Inc. · 201810cite it

What has FDA decided for it lately?

The one decision as Viz.Al, Inc. →