Viz ICH

K193658

Viz.ai, Inc. · cleared 2020-03-18 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Viz ICH is a software-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.”

Algorithmartificial intelligence algorithm

source quote (p.3)

“Viz ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation.”

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=261 scans · 2 site(s)

endpoints: sensitivity; specificity; time to notification

Reported performance (4 observations)

sensitivity0.93CI 87%-97%

source quote (p.7)

“Sensitivity and specificity were 93% (87%-97%) and 90% (84%-94%), respectively.”

specificity0.9CI 84%-94%

source quote (p.7)

“Sensitivity and specificity were 93% (87%-97%) and 90% (84%-94%), respectively.”

aurocas written: “auc”0.96

source quote (p.7)

“In addition, the area under the receiver operating characteristic curve (AUC) was 0.96 demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.”

time_to_resultas written: “Average time to alerting a specialist”0.49CI ±0.15 minutes

source quote (p.8)

“In the study, the average time to alerting a specialist was 0.49±0.15 minutes, which is substantially lower than the average time to notification seen in the Standard of Care of 38.2±84.3 minutes.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K232363 (decision 2024-02-05) from Viz.ai, Inc. for a matching device line ("Viz HDS, Viz Volume Plus, Viz ICH+") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232363
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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K210209 (decision 2021-03-23) from Viz.ai, Inc. for a matching device line ("Viz ICH") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K210209

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).