Viz ICH
K210209Viz.ai, Inc. · cleared 2021-03-23 · product code QAS · Radiology
Premarket evidence — what FDA accepted
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 an appropriate specialist, such as a neurovascular specialist or neurosurgeon, independent of the standard of care workflow.”
source quote (p.5)
“The Viz ICH image analysis software algorithm is an an artificial intelligence machine learning (AI/ML) software algorithm that analyzes non-contract CT images of the head for an intracranial hemorrhage.”
Validation studies (1)
Retrospective clinical
n=387 cases · 2 site(s)
endpoints: pre-specified performance goals of 80% for sensitivity and specificity
Reported performance (4 observations)
source quote (p.7)
“Sensitivity and specificity were 95% (91% - 98%) and 96% (92% - 98%), respectively.”
source quote (p.7)
“Sensitivity and specificity were 95% (91% - 98%) and 96% (92% - 98%), respectively.”
source quote (p.7)
“In addition, the area under the receiver operating characteristic curve (AUC) was 0.97, demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.”
source quote (p.7)
“In the study, the average time to alerting a specialist was 0.49±0.08 minutes, which is lower than the average time to notification seen in the Standard of Care of 18.3±14.2 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
- 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
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).