Viz HDS, Viz Volume Plus, Viz ICH+

K232363

Viz.ai, Inc. · cleared 2024-02-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to processes non-contrast head CT scans to outline intracranial hyperdensity areas, lateral ventricles (right and left), midline shift, and then quantify the volume of intracranial hyperdensity(ies), volume of lateral ventricles, lateral ventricle asymmetry ratio and distance of midline shift.”

Algorithmartificial intelligence machine learning (AI/ML) algorithm; deep-learning algorithm

source quote (p.5)

“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to processes non-contrast head CT scans to outline intracranial hyperdensity areas, lateral ventricles (right and left), midline shift, and then quantify the volume of intracranial hyperdensity(ies), volume of lateral ventricles, lateral ventricle asymmetry ratio and distance of midline shift. Both the subject device and the predicate device use a deep-learning algorithm that analyzes NCCT images for identifying, labeling and quantifying volume of segmentable brain structures.”

Adaptive (vs locked)No

source quote (p.5)

“Viz HDS is a software-only device that uses a locked artificial intelligence machine learning (AI/ML) algorithm to processes non-contrast head CT scans to outline intracranial hyperdensity areas, lateral ventricles (right and left), midline shift, and then quantify the volume of intracranial hyperdensity(ies), volume of lateral ventricles, lateral ventricle asymmetry ratio and distance of midline shift.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: MAE for hyperdensities total volume; MAE for right lateral ventricle volume; MAE for left lateral ventricle volume; MAE for midline shift distance

Retrospective clinical

sample size not stated

endpoints: DICE score for hyperdensity(ies); DICE score for both lateral ventricles

Reported performance (2 observations)

diceas written: “DICE score for hyperdensity(ies)”stated without valueCI lower CI bound was greater than 70%

source quote (p.10)

“The study demonstrated that the DICE score for hyperdensity(ies) and both lateral ventricles lower CI bound was greater than 70%, which was aligned with the performance goal.”

diceas written: “DICE score for lateral ventricles”stated without valueCI lower CI bound was greater than 70%

source quote (p.10)

“The study demonstrated that the DICE score for hyperdensity(ies) and both lateral ventricles lower CI bound was greater than 70%, which was aligned with the performance goal.”

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

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).